FDA Updates

Medline CHEST TUBE INSERTION TRAY ADUL, REF CHT1165; medical procedure convenience kit

Reason: It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Root cause: Under Investigation by firm

Medline IV TEAM PICC, REF DYNJ48222; medical procedure convenience kit

Reason: It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Root cause: Under Investigation by firm

Medline PEDIATRIC DRAPE PK, REF DYNJ81297; medical procedure convenience kit

Reason: It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Root cause: Under Investigation by firm

Medline TUBAL LIGATION PACK, REF DYNJ66230B; medical procedure convenience kit

Reason: It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Root cause: Under Investigation by firm

Medline brand medical procedure convenience kits, labeled as: a) UNIVERSAL DRAPE PACK, REF DYNJ44114; b) DRAPE PACK, REF DYNJ82663B

Reason: It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Root cause: Under Investigation by firm

Medline AMBULATORY MINI PACK, REF DYNJ82579; medical procedure convenience kit

Reason: It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Root cause: Under Investigation by firm

Medline brand medical procedure convenience kits, labeled as: a) NEURO PACK, REF DYNJ37909A; b) SHUNT PACK, REF DYNJ40040C

Reason: It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Root cause: Under Investigation by firm

Medline brand medical procedure convenience kits, labeled as: 1) L&D/OB PACK-LF, REF DYNJ0213264O; 2) VAG DELIVERY HLTH ALLIA PK-LF, REF DYNJ0375486K; 3) VAG DELIVERY HLTH ALLIA PK-LF, REF DYNJ0375486K; 4) VAGINAL DELIVERY, REF DYNJ04865M; 5) VAGINAL DELIVERY PACK-LF, REF DYNJ0536939R; 6) LABOR & DELIVERY-LF, REF DYNJ07831F; 7) DELIVERY PACK-LF, REF DYNJ09982A; 8) DELIVERY PACK-LF, REF DYNJ09982A; 9) DELIVERY ROOM PACK, REF DYNJ14193C; 10) OB PACK, REF DYNJ17486I; 11) OB PACK, REF DYNJ17486I; 12) DELIVERY PACK, REF DYNJ24339K; 13) DELIVERY PACK, REF DYNJ26935A; 14) DELIVERY PACK, REF DYNJ26935A; 15) OB/DELIVERY ROOM PACK, REF DYNJ27262F; 16) VAGINAL DELIVERY TRAY, REF DYNJ27275; 17) VAGINAL DELIVERY, REF DYNJ28437F; 18) OB PACK, REF DYNJ31817K; 19) OB PACK, REF DYNJ31817K; 20) OB PACK, REF DYNJ36010F; 21) OB PACK, REF DYNJ38804G; 22) VAGINAL PACK, REF DYNJ40037A; 23) VAGINAL DELIVERY, REF DYNJ40170A; 24) VAG RECTAL PACK BWH-LF, REF DYNJ41694B; 25) OB DELIVERY PACK, REF DYNJ41994; 26) DELIVERY BUNDLE KIT, REF DYNJ43370A; 27) DELIVERY ROOM PACK, REF DYNJ44328G; 28) OB PACK, REF DYNJ44500F; 29) DELIVERY PACK, REF DYNJ47621A; 30) OB PACK, REF DYNJ50482G; 31) DELIVERY PACK, REF DYNJ52966C; 32) DELIVERY PACK, REF DYNJ57567; 33) LABOR & DELIVERY PACK, REF DYNJ57598; 34) OB DELIVERY PACK, REF DYNJ60784B; 35) VAGINAL DELIVERY PACK, REF DYNJ61662; 36) VAGINAL DELIVERY PACK, REF DYNJ61662; 37) LABOR AND DELIVERY PACK, REF DYNJ61864A; 38) PK, L&D-VAG DEL-MH, REF DYNJ62512A; 39) PK, L&D-VAG DEL-MH, REF DYNJ62512A; 40) VUWC OB PACK, REF DYNJ64017B; 41) OB PACK, REF DYNJ65525B; 42) VAG DELIVERY PACK, REF DYNJ66415; 43) VAGINAL DELIVERY PACK, REF DYNJ66970; 44) VAG DELIVERY, REF DYNJ67089; 45) VAGINAL DELIVERY PACK, REF DYNJ67111; 46) VAGINAL DELIVERY PACK, REF DYNJ67111; 47) AOMC MIDWIFE PACK, REF DYNJ67588; 48) VAGINAL DELIVERY TRAY, REF DYNJ68131A; 49) DELIVERY L&D PACK-CLEAR LAKE, REF DYNJ68247C; 50) DELIVERY L & D PACK, REF DYNJ68251D; 51) DELIVERY L & D PACK, REF DYNJ68251D; 52) SS VAGINAL DELIVERY PACK, REF DYNJ69512; 53) VAGINAL DELIVERY PACK, REF DYNJ69544A; 54) DELIVERY, REF DYNJ69721; 55) VAGINAL PACK, REF DYNJ69774A; 56) LABOR & DELIVERY PACK, REF DYNJ69833; 57) VAGINAL DELIVERY, REF DYNJ80532A; 58) OB PACK, REF DYNJ81878; 59) VAGINAL DELIVERY DISP PACK, REF DYNJ81917; 60) GENERAL DELIVERY PACK, REF DYNJ82447; 61) VAGINAL DELIVERY PACK, REF DYNJ82489B; 62) OB PACK, REF DYNJ82923; 63) OB PACK III, REF DYNJ82945; 64) OB PACK, REF DYNJ83196; 65) OB PACK, REF DYNJ83515; 66) 3027240 OB DELIVERY PACK, REF DYNJ84730; 67) DELIVERY PACK, REF DYNJ85860; 68) LABOR AND DELIVERY, REF DYNJ907794A; 69) LABOR AND DELIVERY, REF DYNJ907794A; 70) LABOR AND DELIVERY, REF DYNJ907794A; 71) VAGINAL DELIVERY, REF DYNJ908636A; 72) LABOR & DELIVERY PK I-LF, REF DYNJT0104G; 73) PACK VAGINAL DELIVERY, REF HM190A; 74) VAGINAL DELIVERY PACK-LF, REF PHS410140008D; 75) VAGINAL DELIVERY PACK, REF SYNJ10248B; 76) VAGINAL DELIVERY PACK, REF SYNJ10248B

Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY PACK, REF DYNJ24362C; b) MAJOR GYNE LAPAROSCOPY SHSC, REF DYNJ46774B; c) GYN ANCILARY PACK, REF DYNJ84509; d) GYN LITHOTOMY MINOR, REF DYNJ907707

Reason: It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Root cause: Under Investigation by firm

Medline brand medical procedure convenience kits, labeled as: a) ABDOMINAL HYSTERECTOMY TEGH-LF, REF DYNJ46730; b) HYSTEROSCOPY PACK, REF DYNJ49302A; c) PERI GYN PACK, REF DYNJ57526A; d) HYSTEROSCOPY TRAY ACS, REF DYNJ68750

Reason: It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Root cause: Under Investigation by firm

Medline brand medical procedure convenience kits, labeled as: a) OB PACK-LF, REF DYNJ0912449M; b) OB PACK, REF DYNJ17309G; c) OB PK, REF DYNJ34268D; d) OB DELIVERY PACK, REF DYNJ34274B; e) OB DELIVERY PACK, REF DYNJ34274B; f) D AND C PACK, REF DYNJ39668I; g) OB PACK, REF DYNJ42884; h) RFT D & C PACK, REF DYNJ50851; i) KIT OB, REF DYNJ906623; j) D AND C, REF DYNJ907957A; k) CHS OB PACK III, REF DYNJCH907

Reason: It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Root cause: Under Investigation by firm

Medline brand medical procedure convenience kits, labeled as: 1) EYE PACK, REF DYNJ19492L; 2) PHACO PACK, REF DYNJ22354L; 3) EYE PACK, REF DYNJ24573K; 4) EYE PACK, REF DYNJ30327A; 5) BASIC CATARACT PACK, REF DYNJ36868F; 6) BASIC RETINA PACK, REF DYNJ40811A; 7) OPHTHALMOLOGY PACK CKHA-LF, REF DYNJ41769A; 8) CATARACT PACK WRO-LF, REF DYNJ41861; 9) EYE PACK, REF DYNJ43911; 10) PHACO PACK, REF DYNJ44748I; 11) DR DRUMMOND EYE PACK, REF DYNJ45344G; 12) OPHTHALMIC PACK, REF DYNJ47275A; 13) CATARACT PACK, REF DYNJ49412B; 14) CATARACT PACK, REF DYNJ50948A; 15) CATARACT PACK, REF DYNJ50948A; 16) CATARACT DR MALONE PACK, REF DYNJ51590A; 17) CATARACT DR MALONE PACK, REF DYNJ51590A; 18) CUSTOM EYE TRAY, REF DYNJ51821B; 19) EYE SURGERY PACK, REF DYNJ53097C; 20) CATARACT KIT, REF DYNJ53944; 21) EYE PACK, REF DYNJ54847D; 22) PK, OPHTH-EYE, REF DYNJ55070B; 23) EYE PACK, REF DYNJ55320D; 24) PK, OPHTH-RETINA, REF DYNJ59253B; 25) RETINA PACK, REF DYNJ60515; 26) ASED KIT, REF DYNJ60745D; 27) CATARACT PACK, REF DYNJ61321B; 28) EYE PACK, REF DYNJ61862A; 29) CATARACT PACK DR FREDERICK, REF DYNJ63163; 30) CATARACT DR ESTOPINAL, REF DYNJ63164; 31) EYE CATARACT (BASIC EYE), REF DYNJ63272C; 32) EYE CATARACT (BASIC EYE), REF DYNJ63272C; 33) HMSL EYE PACK, REF DYNJ64537A; 34) EYE PACK, REF DYNJ65271C; 35) CMC ODS OPHTHALMIC PACK, REF DYNJ66832; 36) BASIC CATARACT PACK, REF DYNJ69165D; 37) BASIC CATARACT PACK, REF DYNJ69165D; 38) LIFESPAN VITRECTOMY PACK, REF DYNJ80082; 39) CATARACT PACK WITH NO TUB, REF DYNJ80232; 40) RETINA PACK, REF DYNJ80483; 41) RETINA PACK, REF DYNJ81640; 42) WESTFALL OCCUPLASTY, REF DYNJ81796A; 43) EYE PACK, REF DYNJ83799C; 44) OPHTHALMIC PACK, REF DYNJ85275; 45) CATARACT, REF DYNJ908059A; 46) EYE TRAY 1-LF, REF LLSCAEYE01A; 47) PHACO PACK, REF LYN011PHNHD; 48) PHACO PACK, REF LYN011PHNHD; 49) SPECIALTY BESSER PACK, REF LYN023BPSSD; 50) SPECIALTY BESSER PACK, REF LYN023BPSSD; 51) SPECIALTY BESSER PACK, REF LYN023BPSSD; 52) BASIC OPHTHALMIC PACK, REF LYN023BSBLB; 53) BASIC OPHTHALMIC PACK, REF LYN023BSBLB; 54) OPHTHALMIC PACK, REF LYN023OPSOB; 55) CATARACT PACK CLEARSIGHT CTR, REF LYN024CACSB; 56) BASIC CATARACT PACK, REF LYN030BCSDB; 57) CATARACT PACK SEVEN SPRINGS, REF LYN030CPSSA; 58) AIKEN CATARACT PACK II, REF LYN030CTAKG; 59) AIKEN CATARACT PACK II, REF LYN030CTAKG; 60) AIKEN CATARACT PACK II, REF LYN030CTAKG; 61) VA EYE II-LF, REF LYN030VAEYA; 62) VA EYE II-LF, REF LYN030VAEYA; 63) CATARACT PACK, REF LYN035CTSEC; 64) EYES OF YORK DR BENZ CATARACT, REF LYN037DBEYM; 65) EYES OF YORK DR BENZ CATARACT, REF LYN037DBEYM; 66) OPHTHALMIC PACK, REF LYN041OPFCC; 67) OPHTHALMIC PACK, REF LYN041OPFCC; 68) OPHTHALMIC PACK, REF LYN041OPFCC; 69) OPHTHALMIC PACK, REF LYN041OPFCC; 70) CATARACT PACK, REF LYN042CPFEG; 71) OPTHALMIC PACK-LF, REF PHS529724000B; 72) CATARACT PACK, REF VAL001CPMEB; 73) CATARACT PACK, REF VAL001CPMEB; 74) THE SURGERY CENTER CATARACT, REF VAL002CATSG; 75) THE SURGERY CENTER CATARACT, REF VAL002CATSG; 76) RETINA PACK PIEDMONT EYE, REF VAL003REPEA; 77) CATARACT PACK, REF VAL009CAAHC; 78) RENAISSANCE CAT PACK, REF VAL009CAREA; 79) CATARACT TENAYA SURGERY CENTER, REF VAL009CATEA; 80) CATARACT PACK, REF VAL009CTSGA; 81) DOUGHERTY LASER VISION- NEW II, REF VAL009EYDLC; 82) RETINA PACK-TRINITY GROUP, REF VAL009RETGA; 83) RENAISSANCE VIT PACK, REF VAL009VIREA; 84) CATARACT PACK APERTURE, REF VAL011CTVAA; 85) OPHTHALMIC PACK, REF VAL022BSOMD; 86) CATARACT PACK - INST OF OKLA, REF VAL024CAIOD; 87) EYE PACK, REF VAL024EYTRB; 88) CATARACT PACK, REF VAL026CTNFC; 89) EYE PACK, REF VAL029EYGSB; 90) INTRAOCULAR PACK, REF VAL031IOGCB; 91) CATARACT, REF VAL035CPAEC; 92) CATARACT PACK 2, REF VAL036CABRD; 93) BRINTON VISION ICL PACK, REF VAL037ICBVG; 94) EYE PACK, REF VAL038BSCID; 95) CATARACT PACK EYECARE CONSULT, REF VAL038CTECB; 96) EYE PACK SC OF SOUTHWOODS, REF VAL041EPSWA; 97) BOOZMAN HOF PACK 2, REF VAL042EYBHC; 98) CATARACT PACK WILD

Medline brand medical procedure convenience kits, labeled as: 1) NEW LONDON TOTAL KNEE CDS, REF CDS982519W; 2) HAND/FOOT CDS, REF CDS984003A; 3) SPECIAL PROCEDURE PACK, REF DYNJ32639C; 4) PK-ORTHO-MINOR, REF DYNJ39547B; 5) ANT CERV ADD ON PACK, REF DYNJ41229C; 6) NAVIGATIONAL SPINE FUSION, REF DYNJ45153B; 7) FEET, ELBOW, AND ANKLE TEGH-LF, REF DYNJ46719B; 8) PLASTIC HAND PACK TEGH-LF, REF DYNJ46739B; 9) CVL INSERTION KIT-LF, REF DYNJ48587A; 10) CVL INSERTION KIT-LF, REF DYNJ48587A; 11) ENSEMBLE SURPLUS LCA-LF, REF DYNJ48892C; 12) EXTREMITY PACK, REF DYNJ49301B; 13) ACL ACCESSORY PACK, REF DYNJ50952F; 14) SPINAL INJECTION PACK, REF DYNJ51383F; 15) FTMC ARTHROS BASIC SETUP-LF, REF DYNJ54602A; 16) MINOR EXTREMITY PACK, REF DYNJ55324G; 17) MINOR EXTREMITY PACK, REF DYNJ55324G; 18) D-SPINE SUPPLEMENT PACK, REF DYNJ58115A; 19) EXTREMITY PACK, REF DYNJ62877; 20) AHT LG KNEE ROLL, REF DYNJ64823; 21) CUSTOM ORTHO PACK, REF DYNJ83675; 22) DR SUNDAR SCS KIT, REF DYNJ85288A; 23) CENTRAL SCS TRIAL PACK, REF DYNJ85503; 24) TOTAL KNEE CDS-LF, REF DYNJ909569; 25) EXTREMITY PACK, REF SYNJ10253B; 26) CARROLLTON HIP FX, REF SYNJ910003A; 27) ARTHROSCOPY, REF SYNJ910004C

Reason: It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Root cause: Under Investigation by firm

Medline EYE PACK, REF LYN036EPESB; medical procedure convenience kit

Reason: It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Root cause: Under Investigation by firm

Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100

Reason: It was discovered during device performance testing that the CCD imaging sensors were programmed with the incorrect color correction data and therefore, specifications are not met.

Root cause: Under Investigation by firm

medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2

Reason: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

Root cause: Process control

medex TranStar Single ICP Set 1/EA, Product Code REF MX20897

Reason: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

Root cause: Process control

medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086

Reason: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

Root cause: Process control

medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1

Reason: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

Root cause: Process control

medex TranStar Kit w/ Stopcock1/EA, Product Code REF MX20740

Reason: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

Root cause: Process control