FDA Updates

Medline Convenience kits labeled as: HSG TRAY, Pack Number DYNDH1453

Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Root cause: Under Investigation by firm

Medline Convenience kits labeled as: 1) PACK VAGINAL DELIVERY , Pack Number AM185B ; 2) LABOR & DELIVERY CDS, Pack Number CDS830039AF; 3) LABOR & DELIVERY CDS, Pack Number CDS830039AI; 4) LABOR & DELIVERY CDS, Pack Number CDS830039AJ; 5) LABOR & DELIVERY CDS, Pack Number CDS830039AK; 6) VAGINAL DELIVERY CDS, Pack Number CDS830053G ; 7) VAGINAL DELIVERY CDS, Pack Number CDS830053I ; 8) LABOR & DELIVERY, Pack Number CDS830054P ; 9) VAGINAL DELIVERY PACK-LF, Pack Number CDS830116T ; 10) VAG DELIVERY, ROSCOE, Pack Number CDS830118Q ; 11) VAG DELIVERY, ROSCOE, Pack Number CDS830118R ; 12) VAG DELIVERY, ROSCOE, Pack Number CDS830118S ; 13) VAG DELIVERY, ROSCOE, Pack Number CDS830118T ; 14) VAGINAL DEL/RECOV CDS , Pack Number CDS830131J ; 15) VAGINAL DEL/RECOV CDS , Pack Number CDS830131K ; 16) VAGINAL DEL/RECOV CDS , Pack Number CDS830131L ; 17) MAJOR VAGINAL PROCEDURE , Pack Number CDS830136S ; 18) VAGINAL DELIVERY PROCEDURE, Pack Number CDS830137O ; 19) VAGINAL DELIVERY PROCEDURE, Pack Number CDS830137P ; 20) VAGINAL DELIVERY CDS, Pack Number CDS830140A ; 21) VAGINAL DELIVERY CDS, Pack Number CDS830140B ; 22) VAGINAL DELIVERY CDS, Pack Number CDS830178K ; 23) VAGINAL DELIVERY CDS, Pack Number CDS830178L ; 24) VAGINAL DELIVERY CDS, Pack Number CDS830178M ; 25) VAGINAL HYSTERECTOMY CDS, Pack Number CDS830186O ; 26) DELIVERY CDS, Pack Number CDS830199K ; 27) DELIVERY CDS, Pack Number CDS981282O ; 28) OB PROCEDURE-LF , Pack Number CDS981335B ; 29) VAG HYSTERECTOMY CDS, Pack Number CDS981517G ; 30) VAGINAL DELIVERY CDS, Pack Number CDS981776I ; 31) VAGINAL DELIVERY CDS, Pack Number CDS981776J ; 32) VAGINAL DELIVERY CDS, Pack Number CDS981776K ; 33) VAGINAL HYSTERECTOMY CDS, Pack Number CDS982369F ; 34) VAGINAL MAJOR , Pack Number CDS982689O ; 35) VAGINAL MAJOR , Pack Number CDS982689P ; 36) VAGINAL MAJOR , Pack Number CDS982689Q ; 37) VAGINAL MAJOR , Pack Number CDS982689R ; 38) DELIVERY PROCEDURE, Pack Number CDS982761F ; 39) DELIVERY PROCEDURE, Pack Number CDS982761G ; 40) DELIVERY PROCEDURE, Pack Number CDS982761I ; 41) DELIVERY PROCEDURE, Pack Number CDS982761J ; 42) VAGINAL DELIVERY CDS, Pack Number CDS982762D ; 43) VAGINAL DELIVERY CDS, Pack Number CDS982762F ; 44) VAGINAL DELIVERY CDS, Pack Number CDS982762G ; 45) VAGINAL DELIVERY CDS, Pack Number CDS982762I ; 46) VAGINAL DELIVERY CDS, Pack Number CDS982770B ; 47) MAG MAJOR VAGINAL CDS , Pack Number CDS982907K ; 48) MAG MAJOR VAGINAL CDS , Pack Number CDS982907L ; 49) MAG MINOR VAGINAL CDS , Pack Number CDS982908I ; 50) MAG MINOR VAGINAL CDS , Pack Number CDS982908J ; 51) OB-VAGINAL DELIVERY/EMERGENCY , Pack Number CDS982959; 52) VAGINAL DELIVERY CDS, Pack Number CDS983090C ; 53) VAGINAL HYSTERECTOMY CDS, Pack Number CDS983107G ; 54) LABOR & DELIVERY CDS, Pack Number CDS983116C ; 55) LABOR & DELIVERY CDS, Pack Number CDS983116D ; 56) LABOR & DELIVERY CDS, Pack Number CDS983116F ; 57) LABOR & DELIVERY CDS, Pack Number CDS983116G ; 58) LABOR & DELIVERY CDS, Pack Number CDS983116I ; 59) MINOR VAGINAL CDS , Pack Number CDS983119B ; 60) VAGINAL MINOR , Pack Number CDS983268J ; 61) VAGINAL MINOR , Pack Number CDS983268L ; 62) GYN VAGINAL CDS , Pack Number CDS983528J ; 63) ACH MAJOR VAGINAL , Pack Number CDS983641F ; 64) ACH MAJOR VAGINAL , Pack Number CDS983641G ; 65) VAG HYST CDS, Pack Number CDS983697F ; 66) VAGINAL DELIVERY CDS, Pack Number CDS983919C ; 67) VAGINAL DELIVERY CDS, Pack Number CDS983919D ; 68) VAGINAL DELIVERY CDS, Pack Number CDS983919F ; 69) VAGINAL DELIVERY CDS, Pack Number CDS983919G ; 70) OB/GYN CDS, Pack Number CDS984173G ; 71) OB GYN, Pack Number CDS984173I ; 72) GROTH VAGINAL CDS , Pack Number CDS984201P ; 73) GROTH VAGINAL CDS , Pack Number CDS984201Q ; 74) GROTH VAGINAL CDS , Pack Number CDS984201R ; 75) GROTH VAGINAL CDS , Pack Number CDS984201U ; 76) NHP VAGINAL MINOR CDS , Pack Number CDS984235F ; 77) VAGINAL DELIVERY CDS, Pack Number CDS984352C ; 78) VAGINAL DELIVERY CDS, Pack

Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Root cause: Under Investigation by firm

Medline Convenience kits labeled as: 1) GROTH PELVISCOPY CDS, Pack Number CDS984187T ; 2) GROTH PELVISCOPY, Pack Number CDS984187U ; 3) DERMATOLOGY KIT, Pack Number DYNDA1567D; 4) ER MINOR SUTURE SET, Pack Number DYNDA1977A; 5) HSG TRAY, Pack Number DYNDH1453; 6) TRAY, ER LACERATION, Pack Number DYNDL1569A; 7) LAP/PELVISCOPY CSTM PK-LF , Pack Number DYNJ0157511K ; 8) SMSC-PELVISCOPY PACK-LF , Pack Number DYNJ0161619I ; 9) LAPAROSCOPY/PELVISCOPY PACK-LF, Pack Number DYNJ0477038K ; 10) LITHOTOMY/PELVISCOPY PACK , Pack Number DYNJ0531985R ; 11) GYN PELVISCOPY PACK-LF, Pack Number DYNJ0537705L ; 12) SM-PELVISCOPY PACK-LF , Pack Number DYNJ0780009W ; 13) SM-PELVISCOPY PACK-LF , Pack Number DYNJ0780009Y ; 14) PELVISCOPY PACK-LF, Pack Number DYNJ0843760I ; 15) PELVISCOPY PACK-LF, Pack Number DYNJ0843760J ; 16) PELVISCOPY LAP-LF , Pack Number DYNJ40099B ; 17) PELVISCOPY LAP-LF , Pack Number DYNJ40099C ; 18) PELVISCOPY GYN LAP PACK , Pack Number DYNJ40608D ; 19) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595N ; 20) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595O ; 21) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595P ; 22) RFLAP PELVISCOPY PCK(LPLUH)-LF, Pack Number DYNJ47703G ; 23) PELVISCOPY PACK , Pack Number DYNJ50688D ; 24) PELVISCOPY PACK , Pack Number DYNJ50688F ; 25) HHI LITHOTOMY PELVISCOPY PACK , Pack Number DYNJ51918D ; 26) PELVIC LAP, Pack Number DYNJ53601G ; 27) VAGINAL PACK, Pack Number DYNJ59786B ; 28) PELVIC PACK , Pack Number DYNJ63057D ; 29) PELVIC PACK , Pack Number DYNJ63057F ; 30) PERI GYN, Pack Number DYNJ64239B ; 31) OB GYN PACK , Pack Number DYNJ80831; 32) MON OB GYN PACK , Pack Number DYNJ80831A ; 33) MON OB GYN PACK , Pack Number DYNJ80831B ; 34) LAP PELVISCOPY PACK , Pack Number DYNJ82449; 35) PELVISCOPY PACK , Pack Number DYNJ82555; 36) PELVISCOPY PACK , Pack Number DYNJ82555A ; 37) PELVISCOPY, Pack Number DYNJ82676; 38) PERIPELVIC PACK , Pack Number DYNJ83912; 39) PELVISCOPY PACK , Pack Number DYNJ84379; 40) PELVISCOPY PACK , Pack Number DYNJ85311; 41) D-PELVISCOPY, Pack Number DYNJ900628I; 42) PELVISCOPY, Pack Number DYNJ901655F; 43) PELVISCOPY, Pack Number DYNJ901655G; 44) PELVISCOPY, Pack Number DYNJ908446B; 45) NILES LAP PELVIC-LF , Pack Number DYNJ908459A; 46) NILES LAP PELVIC RFID-LF, Pack Number DYNJ908459B

Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Under Investigation by firm

Medline Convenience kits labeled as: 1) LAVH CDS, Pack Number CDS760049AB; 2) TUBAL LIGATION CDS, Pack Number CDS760053D ; 3) TUBAL LIGATION CDS, Pack Number CDS760053G ; 4) TUBAL LIGATION CDS, Pack Number CDS760053I ; 5) TUBAL LIGATION CDS, Pack Number CDS760053J ; 6) GYN LAPAROSCOPY-LF, Pack Number CDS760059F ; 7) GYN LAPAROSCOPY-LF, Pack Number CDS760059G ; 8) GYN LAPAROSCOPY-LF, Pack Number CDS760059I ; 9) GYN LAPAROSCOPY-LF, Pack Number CDS760059J ; 10) LIVER TRANSPLANT #57 CDS-2, Pack Number CDS860063R ; 11) GYN LAP , Pack Number CDS860087L ; 12) GYN LAPAROSCOPY CDS , Pack Number CDS860119Q ; 13) GYN LAPAROSCOPY CDS , Pack Number CDS860119R ; 14) GYN LAPAROSCOPY CDS , Pack Number CDS860119S ; 15) GYN LAPAROSCOPY CDS , Pack Number CDS860119U ; 16) GYN LAPAROSCOPY-LF, Pack Number CDS920074X ; 17) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099Q ; 18) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099R ; 19) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099S ; 20) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099SH; 21) GYN LAPAROSCOPY CDS-LF, Pack Number CDS920105D ; 22) GYN LAPAROSCOPY CDS-LF, Pack Number CDS920105F ; 23) GYN LAPAROSCOPY CDS-LF, Pack Number CDS920105I ; 24) GYN LAPAROSCOPY CDS , Pack Number CDS920124J ; 25) LAVH CDS, Pack Number CDS920130J ; 26) GYN LAPAROSCOPY CDS , Pack Number CDS930198S ; 27) GYN LAPAROSCOPY CDS , Pack Number CDS930198T ; 28) GYN LAPAROSCOPY CDS , Pack Number CDS930198U ; 29) GYN LAPAROSCOPY CDS , Pack Number CDS930198V ; 30) GYN LAPAROSCOPY CDS , Pack Number CDS930198W ; 31) GYN LAPAROSCOPY CDS , Pack Number CDS930198X ; 32) GYN LAPAROSCOPIC, Pack Number CDS930224I ; 33) GYN LAPAROSCOPY PROCEDURE-LF, Pack Number CDS980258S ; 34) GYN LAPAROSCOPY PROCEDURE-LF, Pack Number CDS980258T ; 35) GYN LAPAROSCOPY PROCEDURE-LF, Pack Number CDS980258U ; 36) ROBOTIC , Pack Number CDS980523M ; 37) ROBOTIC GYN , Pack Number CDS980647K ; 38) GYN LAP PROCEDURE , Pack Number CDS980810O ; 39) GYN LAP PROCEDURE , Pack Number CDS980810P ; 40) GYN LAP PROCEDURE , Pack Number CDS980810Q ; 41) GYN LAPAROSCOPY , Pack Number CDS980843G ; 42) GYN LAPAROSCOPY , Pack Number CDS980843I ; 43) DAVINCI PROCEDURE , Pack Number CDS980864O ; 44) DAVINCI PROCEDURE , Pack Number CDS980864P ; 45) GYN MAJOR CDS , Pack Number CDS980998J ; 46) GYN MAJOR , Pack Number CDS980998L ; 47) GYN ENDOSCOPY KIT , Pack Number CDS981309P ; 48) GYN ENDOSCOPY KIT , Pack Number CDS981309Q ; 49) GYN ENDOSCOPY KIT , Pack Number CDS981309T ; 50) PELVISCOPY CDS, Pack Number CDS981546F ; 51) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583R ; 52) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583S ; 53) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583T ; 54) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583U ; 55) GYN DAVINCI CDS , Pack Number CDS981606F ; 56) ROBOTIC PACK-LF , Pack Number CDS981757Q ; 57) GYN LAPAROSCOPY CDS , Pack Number CDS981880R ; 58) GYN LAPAROSCOPY CDS , Pack Number CDS981880S ; 59) GYN LAPAROSCOPY CDS , Pack Number CDS981880T ; 60) GYN LAPAROSCOPY CDS , Pack Number CDS981880U ; 61) GYN LAPAROSCOPY CDS , Pack Number CDS981880V ; 62) GYN LAPAROSCOPY CDS , Pack Number CDS981880W ; 63) GYN LAPAROSCOPY CDS , Pack Number CDS981880X ; 64) ROBOTIC CDS , Pack Number CDS981882W ; 65) ROBOTIC CDS , Pack Number CDS981882X ; 66) LITHOTOMY CDS , Pack Number CDS981897S ; 67) LITHOTOMY CDS , Pack Number CDS981897T ; 68) GYN LAPAROSCOPY CDS-LF, Pack Number CDS981988I ; 69) GYN LAPAROSCOPY , Pack Number CDS982032U ; 70) GYN LAPAROSCOPY , Pack Number CDS982032V ; 71) GYN LAPAROSCOPY , Pack Number CDS982032W ; 72) GYN LAPAROSCOPY , Pack Number CDS982032X ; 73) GYN LAPAROSCOPY , Pack Number CDS982032Y ; 74) ROBOTIC , Pack Number CDS982046V ; 75) ROBOTIC MAJOR , Pack Number CDS982046X ; 76) ROBOTIC MAJOR , Pack Number CDS982046Y ; 77) LIVER PROCEDURE , Pack Number CDS982106J ; 78) ROBOTIC PROCEDURE , Pack Number CDS982128P ; 79) GYN LAPAROSCOPY CDS , Pack Number CDS982245K ; 80

Medline Convenience kits labeled as: 1) UROLOGY MINOR CDS , Pack Number CDS980371J ; 2) UROLOGY MINOR CDS , Pack Number CDS980371K ; 3) CIRCUMCISION TRAY 1.1 , Pack Number CIT6260A ; 4) CIRCUMCISION TRAY 1.3 CM BELL , Pack Number CIT7740; 5) CIRCUMCISION TRAY , Pack Number DYNDL1813; 6) CIRCUMCISION PACK , Pack Number DYNJ16826M ; 7) CIRCUMCISION PACK , Pack Number DYNJ16826N ; 8) CIRCUMCISION PACK , Pack Number DYNJ16826O ; 9) CIRCUMCISION PACK , Pack Number DYNJ38941D ; 10) CIRCUMCISION PACK , Pack Number DYNJ38941F ; 11) CIRCUMCISION SJHC-LF, Pack Number DYNJ48471D ; 12) CIRCUMCISION SJHC-LF, Pack Number DYNJ48471F ; 13) CRMC UNIVERSAL PACK-LF, Pack Number DYNJ61119C ; 14) D-CIRCUMCISION PACK , Pack Number DYNJ64432; 15) CIRCUMCISION PACK , Pack Number DYNJ64876A ; 16) CIRCUMCISION PACK , Pack Number DYNJ64876B ; 17) PACK,CIRCUMCISION ASC , Pack Number DYNJ906909A

Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Root cause: Under Investigation by firm

Medline Convenience kits labeled as: 1) C-SECTION TRAY, Pack Number AM160B ; 2) C-SECTION TRAY, Pack Number AM160C ; 3) C-SECTION CDS , Pack Number CDS820031I ; 4) C-SECTION CDS , Pack Number CDS820031J ; 5) C-SECTION PACK, Pack Number CDS820081K ; 6) C-SECTION PACK, Pack Number CDS820081L ; 7) C-SECTION CDS , Pack Number CDS820103J ; 8) C-SECTION CDS , Pack Number CDS820103K ; 9) UVALDE C-SECTION CDS, Pack Number CDS820116F ; 10) UVALDE C-SECTION CDS, Pack Number CDS820116G ; 11) C-SECTION CDS , Pack Number CDS820136O ; 12) C-SECTION CDS , Pack Number CDS820136P ; 13) C-SECTION CDS , Pack Number CDS820136Q ; 14) C-SECTION CDS , Pack Number CDS820136R ; 15) C-SECTION CDS , Pack Number CDS820136S ; 16) C-SECTION CDS , Pack Number CDS820136T ; 17) C-SECTION CDS , Pack Number CDS820136U ; 18) C-SECTION CDS , Pack Number CDS820152F ; 19) C-SECTION CDS , Pack Number CDS820152G ; 20) C-SECTION CDS , Pack Number CDS820152I ; 21) C-SECTION CDS , Pack Number CDS980774J ; 22) C-SECTION , Pack Number CDS980774K ; 23) C-SECTION , Pack Number CDS980774L ; 24) C-SECTION , Pack Number CDS980774M ; 25) C-SECTION CDS WOR-LF, Pack Number CDS981707F ; 26) C-SECTION CDS , Pack Number CDS981777L ; 27) C-SECTION CDS , Pack Number CDS981777M ; 28) C-SECTION CDS , Pack Number CDS981777N ; 29) C-SECTION CDS-LF, Pack Number CDS982258F ; 30) C-SECTION CDS-LF, Pack Number CDS982258G ; 31) C-SECTION CDS-LF, Pack Number CDS982258I ; 32) C-SECTION CDS , Pack Number CDS982267F ; 33) C-SECTION CDS , Pack Number CDS982267G ; 34) C-SECTION CDS , Pack Number CDS982267I ; 35) C-SECTION CDS , Pack Number CDS982267J ; 36) C-SECTION CDS , Pack Number CDS982328J ; 37) C-SECTION CDS , Pack Number CDS982328K ; 38) C-SECTION CDS , Pack Number CDS982328L ; 39) C-SECTION CDS , Pack Number CDS982328M ; 40) C-SECTION CDS , Pack Number CDS982328O ; 41) C-SECTION CDS , Pack Number CDS982328P ; 42) C-SECTION CDS , Pack Number CDS982367G ; 43) C-SECTION COMBINED CDS, Pack Number CDS982398G ; 44) C-SECTION COMBINED CDS, Pack Number CDS982398I ; 45) C-SECTION CDS , Pack Number CDS982416O ; 46) C SECTION CDS CHS , Pack Number CDS982739F ; 47) C SECTION CDS CHS , Pack Number CDS982739J ; 48) C-SECTION CDS , Pack Number CDS983117C ; 49) C-SECTION CDS , Pack Number CDS983117D ; 50) C-SECTION CDS , Pack Number CDS983117F ; 51) C-SECTION CDS , Pack Number CDS983117G ; 52) C-SECTION PROCEDURE , Pack Number CDS983450I ; 53) C-SECTION PROCEDURE , Pack Number CDS983450J ; 54) C-SECTION PROCEDURE , Pack Number CDS983450K ; 55) C-SECTION PROCEDURE , Pack Number CDS983450L ; 56) C-SECTION PROCEDURE , Pack Number CDS983450M ; 57) C-SECTION CDS , Pack Number CDS983523D ; 58) C-SECTION CDS , Pack Number CDS983523F ; 59) C-SECTION CDS , Pack Number CDS983523G ; 60) C-SECTION CDS-LF, Pack Number CDS983869I ; 61) C-SECTION-LF, Pack Number CDS983869J ; 62) C-SECTION CDS , Pack Number CDS983897G ; 63) C-SECTION CDS , Pack Number CDS983897I ; 64) C-SECTION CDS , Pack Number CDS983934I ; 65) C-SECTION CDS , Pack Number CDS983998C ; 66) C-SECTION DELIVERY CDS, Pack Number CDS984018; 67) C-SECTION DELIVERY CDS, Pack Number CDS984018A ; 68) C-SECTION CDS , Pack Number CDS984554B ; 69) C SECTION CDS , Pack Number CDS984616A ; 70) C-SECTION CDS , Pack Number CDS984768D ; 71) C-SECTION CDS , Pack Number CDS984768F ; 72) C-SECTION , Pack Number CDS984902G ; 73) C-SECTION , Pack Number CDS984902I ; 74) C-SECTION , Pack Number CDS984902J ; 75) C-SECTION , Pack Number CDS984902K ; 76) C-SECTION CDS , Pack Number CDS985206B ; 77) C-SECTION CDS , Pack Number CDS985257G ; 78) C-SECTION CDS , Pack Number CDS985257I ; 79) C-SECTION CDS , Pack Number CDS985257J ; 80) C-SECTION CDS , Pack Number CDS985257L ; 81) C SECTION , Pack Number CDS985505G ; 82) C-SECTION , Pack Number CDS985560N ; 83) C-SECTION SET-UP PACK , Pack Number CDSOBL122F ; 84) C-SECTION SET-UP PACK , Pack Number CDSOBL122G ; 85) C-SECTION SET-UP PACK , Pack Number CD

Medline Convenience kits labeled as: 1) OFFICE PACK FOR HYSTEROSCOPY, Pack Number C040100; 2) LAVH CDS, Pack Number CDS760049AD; 3) LAVH CDS, Pack Number CDS760049AF; 4) MAJOR LITHOTOMY CDS-LF, Pack Number CDS760056G ; 5) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088Q ; 6) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088R ; 7) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088S ; 8) VAGINAL HYSTERECTOMY CDS, Pack Number CDS830186P ; 9) VAGINAL HYSTERECTOMY CDS, Pack Number CDS830186R ; 10) LAVH CDS, Pack Number CDS920130K ; 11) LAVH PROCEDURE, Pack Number CDS980754R ; 12) LAVH PROCEDURE, Pack Number CDS980754S ; 13) VAG HYST KIT, Pack Number CDS981313L ; 14) VAG HYST KIT, Pack Number CDS981313M ; 15) MINOR LITHOTOMY , Pack Number CDS982037W ; 16) MAJOR LITHOTOMY , Pack Number CDS982052V ; 17) D&C CDS , Pack Number CDS982061K ; 18) LAVH, Pack Number CDS982273Q ; 19) LAVH, Pack Number CDS982273R ; 20) LAVH, Pack Number CDS982273S ; 21) BAP NORTH BASIC MINOR GYN CDS , Pack Number CDS982397C ; 22) D&C HYSTEROSCOPY CDS-LF , Pack Number CDS982602K ; 23) GYN LAP HYSTERECTOMY CDS, Pack Number CDS982662P ; 24) GYN LAP HYSTERECTOMY CDS, Pack Number CDS982662Q ; 25) ABDOMINAL HYSTERECTOMY CDS SJF, Pack Number CDS982669N ; 26) GYN LITHOTOMY CDS SJF-LF, Pack Number CDS982679M ; 27) VAGINAL MAJOR , Pack Number CDS982689S ; 28) VAGINAL MAJOR , Pack Number CDS982689T ; 29) GYN/ABDOMINAL , Pack Number CDS982725K ; 30) GYN/ABDOMINAL , Pack Number CDS982725N ; 31) MAG MAJOR VAGINAL CDS , Pack Number CDS982907J ; 32) MAG MAJOR VAGINAL CDS , Pack Number CDS982907M ; 33) VAG HYST/SLING CDS-3, Pack Number CDS983006D ; 34) TOTAL LAPHYSTERECTOMY CDS , Pack Number CDS983055J ; 35) TOTAL LAPHYSTERECTOMY CDS , Pack Number CDS983055K ; 36) CUH LITHOTOMY CDS , Pack Number CDS983207M ; 37) CUH LITHOTOMY CDS , Pack Number CDS983207N ; 38) VAGINAL MINOR , Pack Number CDS983268I ; 39) LAVH CDS, Pack Number CDS983411I ; 40) LAVH CDS, Pack Number CDS983411J ; 41) LAVH CDS, Pack Number CDS983411K ; 42) LAVH PROCEDURE, Pack Number CDS983449L ; 43) LAVH PROCEDURE, Pack Number CDS983449M ; 44) LAVH PROCEDURE, Pack Number CDS983449N ; 45) LAVH CDS, Pack Number CDS983455C ; 46) MAJOR VAGINAL , Pack Number CDS983497J ; 47) MAJOR VAGINAL , Pack Number CDS983497L ; 48) LAPAROTOMY GYN CDS, Pack Number CDS983529M ; 49) VAG HYST CDS, Pack Number CDS983697J ; 50) GYN LITHOTOMY MAJOR LAC CDS , Pack Number CDS983780I ; 51) GYN MAJOR ABDOMINAL LAC CDS , Pack Number CDS983803K ; 52) GYN MINOR CDS , Pack Number CDS983985G ; 53) GYN ABDOMINAL CDS , Pack Number CDS983988A ; 54) MAJOR GYN LAPAROSCOPY CDS , Pack Number CDS984007C ; 55) TVT CDS , Pack Number CDS984091J ; 56) GROTH VAGINAL CDS , Pack Number CDS984201T ; 57) NHP Abdominal Hyst CDS, Pack Number CDS984234J ; 58) GYN CDS , Pack Number CDS984676C ; 59) TSH VAG HYSTERECTOMY CDS, Pack Number CDS985304; 60) TSH VAG HYSTERECTOMY CDS, Pack Number CDS985304A ; 61) DAVINCI HYSTERECTOMY CDS, Pack Number CDS985344F ; 62) HYSTEROSCOPY/D&C, Pack Number CDS985522G ; 63) MAJOR & MINOR LITHOTOMY , Pack Number CDS985525J ; 64) MAJOR LITHOTOMY , Pack Number CDS985547N ; 65) PROCEDURE TRAY, Pack Number DYNDA2966; 66) PERI-GYN PACK-LF, Pack Number DYNJ0038057A ; 67) TVH TRAY, Pack Number DYNJ00460L ; 68) TVH TRAY, Pack Number DYNJ00460M ; 69) D&C HYSTEROSCOPY PACK-LF, Pack Number DYNJ0046646F ; 70) D&C HYSTEROSCOPY PACK-LF, Pack Number DYNJ0046646G ; 71) LAVH PACK-LF, Pack Number DYNJ00470K ; 72) LAVH PACK-LF, Pack Number DYNJ00470L ; 73) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768D ; 74) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768F ; 75) VAG. HYST TRAY-LF , Pack Number DYNJ0209066N ; 76) PERI GYN PACK-LF, Pack Number DYNJ0362432P ; 77) LAVH PACK-LF, Pack Number DYNJ0372824Q ; 78) VAGINAL HYSTERECTOMY PACK-LF, Pack Number DYNJ0373807I ; 79) VAGINAL HYSTERECTOMY PACK-LF, Pack Number DYNJ0373807J ; 80) VAGINAL HYSTERECTOMY PACK-

Medline Convenience kits labeled as: 1) LABOR & DELIVERY CDS, Pack Number CDS830039AD; 2) FETAL SURGERY CDS-LF, Pack Number CDS840214P ; 3) OB PROCEDURE-LF , Pack Number CDS981335C ; 4) ROBOTIC PACK-LF , Pack Number CDS981757P ; 5) GYN ROBOTIC , Pack Number CDS981826J ; 6) ROBOTIC CDS , Pack Number CDS981882Q ; 7) ROBOTIC CDS , Pack Number CDS981882R ; 8) ROBOTIC UROLOGY CDS , Pack Number CDS981984I ; 9) D&C CDS-WRMC, Pack Number CDS982331N ; 10) LITHOTOMY CDS-WRMC, Pack Number CDS982333O ; 11) LITHOTOMY CDS-WRMC, Pack Number CDS982333P ; 12) DEPAUL DAVINCI CDS, Pack Number CDS982377G ; 13) BAP NORTH BASIC MINOR GYN CDS , Pack Number CDS982397B ; 14) BAP NORTH ROBOTIC SURGERY CDS , Pack Number CDS982407N ; 15) GYN/ABDOMINAL , Pack Number CDS982725M ; 16) ROBOTIC CDS , Pack Number CDS982888D ; 17) ROBOTIC CDS , Pack Number CDS982888F ; 18) ROBOTIC CDS , Pack Number CDS982888G ; 19) ROBOTIC CDS , Pack Number CDS983028D ; 20) ZALE PUMP CDS , Pack Number CDS983187F ; 21) CUH UROLOGY ROBOTIC CDS , Pack Number CDS983190L ; 22) ROBOTIC PROSTATECTOMY CDS , Pack Number CDS983216I ; 23) ROBOTIC CDS-LF, Pack Number CDS983258O ; 24) ROBOTIC CDS-LF, Pack Number CDS983258Q ; 25) VAGINAL MINOR , Pack Number CDS983268K ; 26) CUH GEN/GYN ROBOTIC CDS , Pack Number CDS983375K ; 27) ROBOTIC CDS , Pack Number CDS983399D ; 28) GYN VAGINAL CDS , Pack Number CDS983528L ; 29) GYN VAGINAL CDS , Pack Number CDS983528M ; 30) CELEBRATION ROBOTIC CDS , Pack Number CDS983612C ; 31) DAVINCI PROSTATECTOMY CDS , Pack Number CDS983667F ; 32) ROBOTIC LAP NISSEN CDS, Pack Number CDS983687F ; 33) OB CDS, Pack Number CDS983854B ; 34) OB/GYN CDS, Pack Number CDS984173F ; 35) GROTH VAGINAL , Pack Number CDS984201V ; 36) ROBOTIC LITHOTOMY , Pack Number CDS984454N ; 37) DAVINCI ROBOTIC CDS , Pack Number CDS984463C ; 38) DAVINCI CDS UCC-LF, Pack Number CDS984663G ; 39) GYN CDS , Pack Number CDS984860G ; 40) OB DELIVERY CDS , Pack Number CDS985027I ; 41) OB/GYN CDS RICE , Pack Number CDS985256C ; 42) OB/GYN CDS RICE , Pack Number CDS985256D ; 43) OB/GYN CDS RICE , Pack Number CDS985256F ; 44) OB CDS-LF , Pack Number CDS985320C ; 45) OB, Pack Number CDS985506D ; 46) OB, Pack Number CDS985506F ; 47) OB, Pack Number CDS985506G ; 48) OB, Pack Number CDS985506I ; 49) GYN LAPAROSCOPY , Pack Number CDS985519L ; 50) KIT ROBOTICS GYN, Pack Number DYKMBNDL109A ; 51) TRAY HYSTEROSALPINGOGRAM, Pack Number DYNDE1010A ; 52) PERI-GYN PACK-LF, Pack Number DYNJ0038057; 53) ROBOTICS PACK-LF, Pack Number DYNJ0038258B ; 54) DAVINCI PACK-LF , Pack Number DYNJ0042750; 55) ROBOTICS PACK-LF, Pack Number DYNJ0046667A ; 56) ROBOTIC PACK-LF , Pack Number DYNJ0048814I ; 57) NILES LAP PELVIC PACK-LF, Pack Number DYNJ0101440F ; 58) OB DELIVERY PACK-LF , Pack Number DYNJ0103039B ; 59) D AND C PACK-LF , Pack Number DYNJ0161028C ; 60) D AND C PACK-LF , Pack Number DYNJ0161028F ; 61) D AND C PACK-LF , Pack Number DYNJ0161028G ; 62) PELVISCOPY (SMSC) PACK-LF , Pack Number DYNJ0161619D ; 63) LAP SUPRA CERVICAL PACK-LF, Pack Number DYNJ0161811C ; 64) ROBOT PACK, Pack Number DYNJ01823F ; 65) ROBOTICS PACK-LF, Pack Number DYNJ0193529A ; 66) DELIVERY ROOM PACK-LF , Pack Number DYNJ0287784R ; 67) OB PACK , Pack Number DYNJ03387A ; 68) PERI GYN PACK-LF, Pack Number DYNJ0362432L ; 69) PERI GYN PACK-LF, Pack Number DYNJ0362432M ; 70) OB PACK-LF, Pack Number DYNJ0367126L ; 71) OB PACK-LF, Pack Number DYNJ0367126M ; 72) OB PACK-LF, Pack Number DYNJ0367126N ; 73) BIRTHING PACK-LF, Pack Number DYNJ0367360K ; 74) BIRTHING PACK-LF, Pack Number DYNJ0367360L ; 75) OB DELIVERY PACK-LF , Pack Number DYNJ0374609J ; 76) ANTERIOR CERVICAL PACK-LF , Pack Number DYNJ0378293K ; 77) ANTERIOR CERVICAL PACK-LF , Pack Number DYNJ0378634F ; 78) GENERAL MATERNITY PACK-LF , Pack Number DYNJ0382586I ; 79) ANT CERVICAL DISKECT PACK-LF, Pack Number DYNJ0399835M ; 80) BIRTHING PACK-LF, Pack Number DYNJ0409968D ; 81) AOP/VAGINAL MAJOR PACK-LF , Pack Number DYNJ

Medline Convenience kits labeled as: 1) ADULT DRAWER 5, Pack Number ACC010647A ; 2) TUBAL LIGATION CDS, Pack Number CDS760053K ; 3) CATARACT CDS, Pack Number CDS810010J ; 4) CATARACT CDS, Pack Number CDS810010K ; 5) RETINA-LF, Pack Number CDS810023G; 6) RETINA-LF, Pack Number CDS810023I; 7) RETINA-LF, Pack Number CDS810023J; 8) RETINA-LF, Pack Number CDS810023K; 9) EYE CDS , Pack Number CDS810032L ; 10) EYE CDS , Pack Number CDS810032M ; 11) EYE CDS , Pack Number CDS810032N ; 12) EYE CDS , Pack Number CDS810032O ; 13) GENERAL EYE , Pack Number CDS981693I ; 14) GENERAL EYE , Pack Number CDS981693J ; 15) EYE CDS II, Pack Number CDS981738A ; 16) MUSCLE/EYE CDS, Pack Number CDS982059F ; 17) MUSCLE/EYE CDS, Pack Number CDS982059G ; 18) MUSCLE/EYE CDS, Pack Number CDS982059I ; 19) CATARACT CDS-4, Pack Number CDS983001F ; 20) VITRECTOMY CDS-4, Pack Number CDS983005F ; 21) PTERYGIUM CDS , Pack Number CDS983261D ; 22) PTERYGIUM CDS , Pack Number CDS983261F ; 23) PTERYGIUM CDS , Pack Number CDS983261G ; 24) PLASTIC EYE CDS-LF, Pack Number CDS983753C ; 25) PLASTIC EYE CDS-LF, Pack Number CDS983753D ; 26) RETINA LAC/USC CDS, Pack Number CDS983775I; 27) EYE CDS , Pack Number CDS983916F ; 28) EYE CDS , Pack Number CDS983916G ; 29) CATH CDS, Pack Number CDS984141G ; 30) CATARACT CDS, Pack Number CDS984159C ; 31) CATARACT CDS, Pack Number CDS984159D ; 32) CATARACT CDS, Pack Number CDS984159G ; 33) CATARACT CDS, Pack Number CDS984159I ; 34) VITRECTOMY, Pack Number CDS984258J ; 35) VITRECTOMY, Pack Number CDS984258K ; 36) VITRECTOMY, Pack Number CDS984258L ; 37) CATARACT CDS, Pack Number CDS984343B ; 38) CATARACT CDS, Pack Number CDS984343C ; 39) KIT SURG ONC MINOR, Pack Number DYKMBNDL6B ; 40) KIT SURG ONC MINOR, Pack Number DYKMBNDL6BH; 41) EYE BANK PREP KIT , Pack Number DYNDA2345; 42) LASIK PACK, Pack Number DYNDA2925; 43) EYE PLASTIC KIT, Pack Number DYNDC3196; 44) BIOPSY TRAY , Pack Number DYNDH1854; 45) LACERATION TRAY , Pack Number DYNDL1990; 46) LASIK PACK, Pack Number DYNDM1087; 47) GLENNON EYE PACK, Pack Number DYNJ00098F ; 48) CATARACT PACK , Pack Number DYNJ00260K ; 49) INTRAOCULAR PACK, Pack Number DYNJ00260L ; 50) INTRAOCULAR PACK, Pack Number DYNJ00260M ; 51) EYEPACK , Pack Number DYNJ00874G ; 52) EYEPACK , Pack Number DYNJ00874I ; 53) EYEPACK , Pack Number DYNJ00874J ; 54) EYEPACK , Pack Number DYNJ00874K ; 55) MEC EYE PACK, Pack Number DYNJ0101578F ; 56) MEC EYE PACK, Pack Number DYNJ0101578G ; 57) MEC EYE PACK, Pack Number DYNJ0101578J ; 58) BR EYE PAC, Pack Number DYNJ0101578K ; 59) BR EYE PACK-LF, Pack Number DYNJ0101578L ; 60) CATARACT TRACE PACK-LF, Pack Number DYNJ0101664D ; 61) PEN CATARACT PACK-LF, Pack Number DYNJ0101802D ; 62) PEN CATARACT PACK-LF, Pack Number DYNJ0101802F ; 63) PEN CATARACT PACK-LF, Pack Number DYNJ0101802G ; 64) PEN CATARACT PACK-LF, Pack Number DYNJ0101802I ; 65) PEN CATARACT PACK-LF, Pack Number DYNJ0101802J ; 66) PEN CATARACT PACK-LF, Pack Number DYNJ0101802K ; 67) PEN CATARACT PACK-LF, Pack Number DYNJ0101802L ; 68) PEN CATARACT PACK-LF, Pack Number DYNJ0101802M ; 69) CATARACT PACK , Pack Number DYNJ01263G ; 70) CATARACT PACK , Pack Number DYNJ01263I ; 71) CATARACT PACK , Pack Number DYNJ01263J ; 72) CATARACT PACK-LF, Pack Number DYNJ0129784R ; 73) CATARACT PACK-LF, Pack Number DYNJ0129784RH; 74) TRAY DR. WHITE'S EYE, Pack Number DYNJ0132717F ; 75) PK, OPHTH-EYE-WHITE , Pack Number DYNJ0132717G ; 76) CORNEAL TRANSPLANT PACK , Pack Number DYNJ0141239Q ; 77) RETINAL PACK-LF , Pack Number DYNJ0151148B ; 78) CORNEA (JSI) PACK-LF, Pack Number DYNJ0159122I ; 79) CORNEA (JSI) PACK-LF, Pack Number DYNJ0159122J ; 80) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122K ; 81) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122L ; 82) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122M ; 83) CATARACT PACK-LF, Pack Number DYNJ0159809B ; 84) EYE PACK, Pack Number DYNJ0168810Q ; 85) EYE PBM-LF, Pack Number DYNJ0190619F ; 86) EYE PBM-LF, Pack Num

Medline Convenience kits labeled as: 1) SPECIAL PROCEDURE PACK ARTERI , Pack Number 00-399024X ; 2) ARTHROSCOPY TRAY, Pack Number AM110A ; 3) HIP , Pack Number BM200A ; 4) SHOULDER ARTHROSCOPY, Pack Number BM230A ; 5) KNEE ARTHROSCOPY, Pack Number BM240A ; 6) PODIATRY PACK , Pack Number BM250A ; 7) CRANIOTOMY CDS, Pack Number CDS780025AA; 8) CRANIOTOMY CDS, Pack Number CDS780025AB; 9) CRANIOTOMY CDS, Pack Number CDS780025AC; 10) CRANIOTOMY CDS, Pack Number CDS780025X ; 11) CRANIOTOMY CDS, Pack Number CDS780025Y ; 12) LAMINECTOMY CDS-LF, Pack Number CDS780045M ; 13) LAMINECTOMY CDS-LF, Pack Number CDS780045N ; 14) LAMINECTOMY CDS-LF, Pack Number CDS780045O ; 15) CRANIOTOMY CDS, Pack Number CDS780046O ; 16) CRANI , Pack Number CDS780089V ; 17) CRANI , Pack Number CDS780089W ; 18) CRANI , Pack Number CDS780089X ; 19) CRANIOFACIAL CDS, Pack Number CDS780102K ; 20) CRANIOFACIAL CDS, Pack Number CDS780102L ; 21) TRAUMA/LIVER CDS-LF , Pack Number CDS780104L ; 22) CRANIOTOMY CDS-LF , Pack Number CDS780105K ; 23) CRANIOTOMY CDS-LF , Pack Number CDS780105L ; 24) NEURO LAMINECTOMY-LF, Pack Number CDS780109P ; 25) CRANIOTOMY-LF , Pack Number CDS780111M ; 26) CRANIOTOMY-LF , Pack Number CDS780111N ; 27) CRANIOTOMY-LF , Pack Number CDS780111O ; 28) CRANIOTOMY-LF , Pack Number CDS780111P ; 29) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119U ; 30) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119V ; 31) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119VH; 32) BASIC BACK CDS, Pack Number CDS780147K ; 33) INSTRUMENTED BACK CDS , Pack Number CDS780148O ; 34) LAMINECTOMY CDS , Pack Number CDS780165L ; 35) LAMINECTOMY CDS , Pack Number CDS780165M ; 36) LAMINECTOMY CDS , Pack Number CDS780165N ; 37) LAMINECTOMY CDS , Pack Number CDS780165O ; 38) LAMINECTOMY CDS , Pack Number CDS780165Q ; 39) LAMINECTOMY CDS , Pack Number CDS780165R ; 40) CRANIOTOMY CDS, Pack Number CDS780166Q ; 41) CRANIOTOMY CDS, Pack Number CDS780166R ; 42) CRANIOTOMY CDS, Pack Number CDS780166S ; 43) CRANIOTOMY CDS, Pack Number CDS780166T ; 44) CRANIOTOMY CDS, Pack Number CDS780166U ; 45) CRANIOTOMY CDS, Pack Number CDS780166V ; 46) DR WOLF SPINE CDS , Pack Number CDS780168P ; 47) GLENNON POSTERIOR SPINE FUSION, Pack Number CDS780182O ; 48) SPINAL FUSION CDS , Pack Number CDS780197N ; 49) SPINAL FUSION PACK, Pack Number CDS780197P ; 50) SPINAL FUSION PACK, Pack Number CDS780197Q ; 51) CRANIOT CRANIECT CDS, Pack Number CDS780201N ; 52) LAMINECTOMY CDS , Pack Number CDS780203J ; 53) SPINAL CARE LAMINECTOMY CDS , Pack Number CDS780204P ; 54) SPINAL CARE LAMINECTOMY CDS , Pack Number CDS780204Q ; 55) ANTERIOR CERVICAL CDS , Pack Number CDS780205O ; 56) ANTERIOR CERVICAL CDS , Pack Number CDS780205P ; 57) ANTERIOR CERVICAL CDS , Pack Number CDS780205Q ; 58) CRANIOTOMY CDS, Pack Number CDS780206O ; 59) CRANIOTOMY CDS, Pack Number CDS780206P ; 60) CRANIOTOMY CDS, Pack Number CDS780206R ; 61) ANTERIOR LUMBAR CDS , Pack Number CDS780207S ; 62) ANTERIOR LUMBAR CDS , Pack Number CDS780207T ; 63) NEURO-LAMI CDS, Pack Number CDS780208I ; 64) CRANIOTOMY PROCEDURE, Pack Number CDS780210I ; 65) CRANIOTOMY PROCEDURE, Pack Number CDS780210J ; 66) CRANIOTOMY PROCEDURE, Pack Number CDS780210K ; 67) SPINE CDS , Pack Number CDS780228D ; 68) LAMINECTOMY CDS-LF, Pack Number CDS780235V ; 69) LAMINECTOMY CDS-LF, Pack Number CDS780235W ; 70) LAMINECTOMY CDS-LF, Pack Number CDS780235X ; 71) SPINE CDS-LF, Pack Number CDS780236L ; 72) SPINE CDS-LF, Pack Number CDS780236M ; 73) CRANIOTOMY CDS-LF , Pack Number CDS780237K ; 74) CRANIOTOMY CDS-LF , Pack Number CDS780237L ; 75) SPINAL FUSION , Pack Number CDS860017AA; 76) SPINAL FUSION , Pack Number CDS860017AB; 77) SPINAL FUSION , Pack Number CDS860017AC; 78) FUSION CDS, Pack Number CDS860138D ; 79) FUSION CDS, Pack Number CDS860138F ; 80) FUSION CDS, Pack Number CDS860138G ; 81) LUMBAR, Pack Number CDS860170I ; 82) LUMBAR, Pack Number CDS860170J ; 83) LUMBAR, Pack Numbe

Medline Convenience kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Code 613034700; 2) C SCOPE DISPOSABLE KIT, Pack Code 613034701; 3) C SCOPE DISPOSABLE KIT, Pack Code 613034702

Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Root cause: Under Investigation by firm

Medline Convenience kits labeled as: 1) ARTHROGRAPHY DRAPE PACK , Pack Number 00-399027M ; 2) ARTHROSCOPY CDS , Pack Number CDS940242I ; 3) ARTHROSCOPY-LF, Pack Number CDS940859J ; 4) KNEE ARTHROSCOPY CDS-LF , Pack Number CDS940869U ; 5) ARTHROSCOPY CDS , Pack Number CDS940960I ; 6) ARTHROSCOPY CDS , Pack Number CDS941059L ; 7) ARTHROSCOPY CDS , Pack Number CDS941062K ; 8) ARTHROSCOPY CDS , Pack Number CDS941110L ; 9) ARTHROSCOPY , Pack Number CDS980751I ; 10) ARTHROSCOPY CDS , Pack Number CDS980893; 11) SHOULDER ARTHROSCOPY CDS-LF , Pack Number CDS981003K ; 12) ARTHROSCOPY CDS , Pack Number CDS981011B ; 13) ARTHROSCOPY PROCEDURE , Pack Number CDS981660J ; 14) SHOULDER ARTHROSCOPY CDS, Pack Number CDS982199G ; 15) ARTHROSCOPY CDS , Pack Number CDS982216C ; 16) ARTHROSCOPY CDS-LF, Pack Number CDS982232F ; 17) ARMC ARTHROSCOPY CDS, Pack Number CDS982278K ; 18) ASC SHOULDER ARTHRO CDS SRM-LF, Pack Number CDS982536C ; 19) ARTHROSCOPY PACK, Pack Number CDS982560D ; 20) ARTHROSCOPY CDS , Pack Number CDS982645J ; 21) ARTHROSCOPY CDS-LF, Pack Number CDS982757D ; 22) ARTHROSCOPY CDS , Pack Number CDS983102F ; 23) ARTHROSCOPY CDS-LF, Pack Number CDS983257I ; 24) ARTHROSCOPY CDS , Pack Number CDS983299G ; 25) ARTHROSCOPY CDS , Pack Number CDS983414C ; 26) ARTHROSCOPY SHOULDER, Pack Number CDS983462I ; 27) ARTHROSCOPY CDS SC-LF , Pack Number CDS983740G ; 28) SHOULDER ARTHROTOMY CDS SC-LF , Pack Number CDS983744F ; 29) ARTHROSCOPY CDS , Pack Number CDS983918F ; 30) KNEE ARTHROSCOPY CDS, Pack Number CDS984220I ; 31) ARTHROSCOPY CDS-LF, Pack Number CDS984426G ; 32) ARTHROSCOPY CDS-LF, Pack Number CDS984455C ; 33) ARTHROSCOPY CDS , Pack Number CDS984609B ; 34) ARTHROSCOPY CDS , Pack Number CDS984636A ; 35) ARTHROSCOPY CDS , Pack Number CDS985095D ; 36) ARTHROSCOPY CDS , Pack Number CDS985208B ; 37) ARTHROSCOPY CDS-LF, Pack Number CDS985294A ; 38) ARTHROSCOPY KNEE, Pack Number CDS985508D ; 39) BIOPSY/ARTHROGRAM TRAY, Pack Number DYNDH1115; 40) ARTHROGRAM TRAY , Pack Number DYNDH1134; 41) ARTHROGRAM TRAY , Pack Number DYNDH1243; 42) ARTHROGRAM PACK , Pack Number DYNDH1322; 43) ARTHROGRAM TRAY , Pack Number DYNDH1347; 44) ARTHROGRAM TRAY , Pack Number DYNDH1349; 45) ARTHROGRAM PACK , Pack Number DYNDH1350; 46) BEACH CHAIR SHOULDER PACK-LF, Pack Number DYNJ00040K ; 47) ARTHROGRAM PACK-LF, Pack Number DYNJ0101275A ; 48) ARTHROSCOPY PACK-LF , Pack Number DYNJ0101722C ; 49) ARTHROSCOPY PACK-LF , Pack Number DYNJ0103045G ; 50) ARTHROSCOPY LV - EDOC PACK-LF , Pack Number DYNJ0111409L ; 51) ARTHROSCOPY PACK-LF , Pack Number DYNJ01114D ; 52) ARTHROSCOPY II PACK-LF, Pack Number DYNJ0161097B ; 53) ARTHROSCOPY PACK, Pack Number DYNJ01829F ; 54) ARTHROSCOPY PACK-LF , Pack Number DYNJ0190768L ; 55) ARTHROSCOPY PACK-LF , Pack Number DYNJ0200295Q ; 56) ARTHROSCOPY PACK-LF , Pack Number DYNJ0219853Q ; 57) YUMH/SURGI-CENTER ARTHRO PK-LF, Pack Number DYNJ0244761K ; 58) ARTHRO KNEE PACK, Pack Number DYNJ02579F ; 59) ARTHROSCOPY PACK-LF , Pack Number DYNJ0281409O ; 60) PPSC ARTHROSCOPY PACK-LF, Pack Number DYNJ0303231D ; 61) ARTHROSCOPY PACK-LF , Pack Number DYNJ0365867L ; 62) ARTHROSCOPY PACK-LF , Pack Number DYNJ0366488I ; 63) ARTHROSCOPY PACK-LF , Pack Number DYNJ0373216K ; 64) ARTHROSCOPY PACK-LF , Pack Number DYNJ0373876F ; 65) ARTHROSCOPY PACK-LF , Pack Number DYNJ0374577N ; 66) ARTHROSCOPY PACK-LF , Pack Number DYNJ0376528J ; 67) ARTHROSCOPY PACK-LF , Pack Number DYNJ0377096D ; 68) ARTHROSCOPY PACK-LF , Pack Number DYNJ0378266K ; 69) ARTHROSCOPY PACK-LF , Pack Number DYNJ0382618L ; 70) ARTHROSCOPY PACK-LF , Pack Number DYNJ0390808F ; 71) ARTHROSCOPY PACK-LF , Pack Number DYNJ0399877G ; 72) ARTHROSCOPY PACK-LF , Pack Number DYNJ0406086L ; 73) ARTHROSCOPY PACK-LF , Pack Number DYNJ0410034P ; 74) GYN RESECTOSCOPE PACK-LF, Pack Number DYNJ0415339I ; 75) ARTHROSCOPY PROCEDURE PACK-LF , Pack Number DYNJ0415915I ; 76) ARTHROSCOPY PACK, Pack Number DYNJ04159A ; 77) ARTHROSCOPY PACK-LF , Pa

Medline Convenience kits, containing Shenli syringes, labeled as: 1) LOCAL PACK, Pack Number DYNJ34129C ; 2) FTMC LOCAL PACK-LF, Pack Number DYNJ54607A ; 3) LOCAL PACK, Pack Number DYNJ61839B

Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Root cause: Under Investigation by firm

Medline Convenience kits, labeled as: 1) SUTURING SET PACK ASSY P791011, Pack Number 59112; 2) SUTURE SET, Pack Number DYNDL1984; 3) CLOSING PACK, Pack Number DYNJ68267A ; 4) SUTURING KIT, Pack Number MNS15015 ; 5) SUTURING KIT, Pack Number MNS15015H; 6) SUTURING SET, Pack Number SUT21770 ; 7) SUTURE SET, Pack Number SUT21810 ; 8) SUTURING SET, Pack Number SUT21810H; 9) SUTURE TRAY , Pack Number SUT21830

Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Root cause: Under Investigation by firm

Medline Convenience kits, labeled as: GAMMA NAIL CDS-LF , Pack Number CDS983505K

Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Root cause: Under Investigation by firm

Medline Convenience kits, labeled as: BIOPSY TRAY-LF, Pack Number DYNDH1229

Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Root cause: Under Investigation by firm

Medline Convenience kits, labeled as: 1) BLOOD CULTURE COLLECTION KIT, Pack Number BP115; 2) NICU CNTRL LINE BLOOD DRAW KIT, Pack Number DYLAB1044; 3) NEURO ANGIO PACK, Pack Number DYNDA1431A; 4) BLOOD WITHDRAWAL KIT #2, Pack Number DYNDA1683A; 5) LCPH LAB DRAW KIT , Pack Number DYNDH1641A ; 6) LCPH LAB DRAW KIT , Pack Number DYNDH1641AH; 7) INFUSION CENTER BLOOD DRAW KIT, Pack Number DYNDH1798; 8) BLOOD CULTURE, Pack Number DYNDH1921; 9) BLOOD WITHDRAWAL TRAY, Pack Number DYNDV1588F; 10) BLOOD WITHDRAWAL TRAY , Pack Number DYNDV1588G ; 11) PHLEBECTOMY PK, Pack Number DYNJ84749; 12) ARTHROGRAPH TRAY, Pack Number MNS12670A; 13) BLOOD CULTURE COLLECTION KIT, Pack Number MNS8915; 14) BLOOD CULTURE COLLECTION KIT, Pack Number MNS8915H ; 15) LACERATION TRAY, Pack Number SUT20955

Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Root cause: Under Investigation by firm

Medline Convenience kits, labeled as: 1) KNEE ARTHROSCOPY CDS-LF , Pack Number CDS983874F ; 2) HAND, Pack Number CDS984080F

Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Root cause: Under Investigation by firm

Medline Convenience kits, labeled as: aa1) BURN PACK-LF, Pack Number DYNJ0781678S ; 2) BURN PACK , Pack Number DYNJ0976092P ; 3) BURN PACK-LF, Pack Number DYNJ42829B ; 4) BURN PACK , Pack Number DYNJ54386C ; 5) LARGE BURN PACK , Pack Number DYNJ69770; 6) LARGE BURN PACK , Pack Number DYNJ69770A ; 7) SMALL BURN PACK , Pack Number DYNJ69797; 8) SMALL BURN PACK , Pack Number DYNJ69797A ; 9) BURN PACK-LF, Pack Number DYNJ82534; 10) BURN PACK-LF, Pack Number DYNJ82534H ; 11) BASIC BURN PACK , Pack Number DYNJ82729; 12) BURN PACK , Pack Number DYNJ83254; 13) BURN PACK , Pack Number DYNJ84744

Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Root cause: Under Investigation by firm

Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lumen Hemodialysis Catheters. Please refer to the applicable catheter Instructions for Use for directions on the use of these accessories.

Reason: Due to guidewires being manufactured incorrectly with the guidewires being mis-assembled within the hoop such that the proximal (stiff) end of the guidewire is located at the distal end of the hoop. Injury could occur if the user attempts to insert the proximal end into the patient.

Root cause: Under Investigation by firm