FDA Updates

Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and Nasopore Forte plus 8cm Catalog Number 5400-030-008ITL

Reason: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.

Root cause: Under Investigation by firm

Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S

Reason: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.

Root cause: Under Investigation by firm

Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S

Reason: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.

Root cause: Under Investigation by firm

Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S

Reason: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.

Root cause: Under Investigation by firm

GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077; 2) 2066908-136; 3) 2066908-150; 4) 2088026-003; 5) 2088026-026; 6) 2088026-032; 7) 2088026-043; 8) 2088026-110; 9) 2088026-115; 10) 2088026-132; 11) 2088026-306; 12) 2088026-308; 13) 2088026-406; 14) 2088026-506; 15) 2088026-614; 16) 2088026-713; 17) 2088026-714; 18) 2088026-715; 19) 2088026-723; 20) 2088026-806; 21) 2088026-906; 22) 2088026-936; 23) 2088026-940; 24) 2088026-943; 25) 2088026-946; 26) 2088026-948; 27) 2088026-957; 28) 2088026-959; 29) 2088026-960; 30) 2088026-961; 31) 2088026-962; 32) 2088026-967; 33) 2088026-969; 34) 2088026-970; 35) 2088026-971; 36) 2088026-973; 37) 2088026-985; 38) 2088026-989; 39) 2088026-990; 40) 2088026-993; 41) 2088026-994; 42) 2089629-003; 43) 2100169-001; 44) 2100491-006; 45) 2100491-012; 46) 2102675-010; 47) 2102675-101; 48) 2102676-001; 49) 2104867-001; 50) 2104867-044; 51) 2104867-045; 52) 2111141-004; 53) 5826659-002; 54) 5826659-013; 55) 5826659-014; 56) 5826659-016; 57) 5826659-017; 58) 5826659-018; 59) 5826659-019; 60) 5826659-021; 61) 5826659-022; 62) 5826659-023; 63) 5826659-025; 64) 5826659-026; 65) 5826659-027; 66) 5826659-028; 67) 5826659-029; 68) 5826659-030; 69) 5826659-032; 70) 5826659-033; 71) K1220JWED; 72) K2042VJED.

Reason: There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.

Root cause: Software design

GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; 2) 2049587-009; 3) 2049587-011; 4) 2049587-012; 5) 2049587-015; 6) 2049588-012 ; 7) 2052829-001.

Reason: There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.

Root cause: Software design

GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001; 2) 2033901-001; 3) 2038437-001; 4) 2038437-011; 5) 2038437-012; 6) 2038437-013; 7) 2038437-014; 8) 2038437-0XX; 9) 2098071-004; 10) 2109571-002; 11) 2109571-006; 12) 2109571-010; 13) 2109594-009; 14) 2109594-011; 15) K2090PS; 16) K2090PTED; 17) MANLEGACY114; 18) MANLEGACY64.

Reason: There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.

Root cause: Software design

GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437-001; 3) 2038437-009; 4) 2038437-014; 5) 2038437-015 ; 6) 2038437-0XX; 7) 2109571-007; 8) 2109571-010; 9) 2109571-011; 10) 2109571-012; 11) MANLEGACY111; 12) MANLEGACY112; 13) MANLEGACY47; 14) P00011TS.

Reason: There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.

Root cause: Software design

GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1) 2049587-015; 2) 2066908-086; 3) 2066908-136; 4) 2104867-045.

Reason: There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.

Root cause: Software design

Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact Lenses For Astigmatism, Pearle Vision 1 Day Premium For Astigmatism, REVEAL 1-DAY TORIC, Vision Source Reveal Toric, Voyant 1-Day Premium Toric. Brand Names (OUS only): CADENCE DELUXE 1-DAY TORIC, DUBLAN PREMIUM OXYGEN 1 DAY TORIC, EV LINARIAL TORIC (30), EYEXPERT PURE ASTIGMATISM (30), LENTI!!AS A ASTIGMATISMO 30PK, LENTSOFT DIARIA CONFORT+ SILICONA ASTIGMATISMO, MULTILENS CONTACT ELITE SILICONE 1 DAY TORICS, OPTIONS SUPREME 1 DAY TRC (30), PRIMA + 1 DAY ASTGM (30), PROTECT PLATINUM FOR ASTG (30), SOL- LENS 1 DAY SILICONE PREMIUM TORIC, UGO LENS DAY ADVANCED TORICA, WHITE BOX STENFILCON A TORIC 07536, MEDIFLEX SUP 1D TORIC, Kirkland Signature Toric Premium Daily Disposable, Specsavers easyvision Linarial Toric. Product Name: (Stenfilcon A) Contact Lens Model/Catalog Number: MyDay Toric Product Description: 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged. Component: No

Reason: a limited number of lots were manufactured with an incorrect cylinder power.

Root cause: Process control

Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991R

Reason: Devices may have higher than expected amounts of bacterial endotoxin.

Root cause: Under Investigation by firm

Medline procedure kits labeled as: 1) BILLINGS CLINIC SC HEAD & NECK, Pack Number DYNJ33656C; 2) BLEPH/RHINO PACK, Pack Number DYNJ64669A; 3) DB ENT CSTM PACK-LF, Pack Number DYNJ33585C; 4) DENTAL PACK, Pack Number DYNJ54064; 5) EAR PACK, Pack Number DYNJ68678C; 6) ENT HEAD NECK PACK, Pack Number DYNJ49023D; 7) ENT PACK, Pack Number DYNJ42564B; 8) ENT PACK, Pack Number DYNJ50572; 9) ENT PACK, Pack Number DYNJ45175B; 10) ENT PACK, Pack Number DYNJ65585A; 11) EP PACK, Pack Number DYNJ59171; 12) FUNCTIONAL ENDO SINUS WEILER, Pack Number DYNJ58857A; 13) HEAD & NECK, Pack Number DYNJ902987F; 14) HEAD & NECK PACK, Pack Number DYNJ61295B; 15) HEAD & NECK PACK, Pack Number DYNJ30234B; 16) HEAD & NECK PACK, Pack Number DYNJ50383; 17) HEAD & NECK PACK, Pack Number DYNJ36634K; 18) HEAD & NECK PACK, Pack Number DYNJ66399; 19) HEAD AND NECK PACK-LF, Pack Number DYNJ38402I; 20) MAJOR ENT HARPER PACK-LF, Pack Number DYNJ0161710I; 21) NASAL SINUS PACK-LF, Pack Number DYNJ0751486N; 22) NE NASAL, Pack Number DYNJ03130D; 23) ORL PACK, Pack Number DYNJ63705B; 24) SINUS PACK, Pack Number DYNJ50110B; 25) SINUS PACK, Pack Number DYNJ50110B; 26) T & A PACK, Pack Number DYNJ58811A; 27) THORACIC PACK, Pack Number DYNJ30731M; 28) THYROIDECTOMIE DIAGNOSTIQUE-LF, Pack Number DYNJ42678A; 29) TONSILS & ADENOIDS, Pack Number DYNJ69465; 30) TRANSPHENOIDAL PACK, Pack Number DYNJ46556B;

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 procedure kits labeled as: 1) BREAST PACK-LF, Pack Number DYNJ0956628O; 2) BREAST SURGERY FOAKS, Pack Number DYNJ63577C; 3) CHEST BREAST -LF, Pack Number DYNJCEN04C; 4) DIEP PACK, Pack Number DYNJ60669G; 5) FACE LIFT PACK, Pack Number DYNJ64670B; 6) FREE FLAP A PACK, Pack Number DYNJ40647G; 7) IPMC BREAST PACK-LF, Pack Number DYNJ0665560D; 8) OCULAR PLASTICS PACK, Pack Number DYNJ40356A; 9) OCULOPLASTY PACK-LF, Pack Number DYNJ0252232U; 10) PACK MASTECTOMY COMBO CHRG, Pack Number DYNJ60232A; 11) PLASTIC GENERAL SURGERY - OSC, Pack Number DYNJ43576A; 12) PLASTIC PACK, Pack Number DYNJ00264L; 13) PLASTIC PACK, Pack Number DYNJ49742B; 14) PLASTIC PK II, Pack Number DYNJ14039B; 15) PLASTIC-GENERAL SURGERY PACK, Pack Number DYNJ09866U; 16) PLASTICS FACIAL PACK ST MARY, Pack Number DYNJ45861B; 17) PLASTICS PACK, Pack Number DYNJ68288A

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 procedure kits labeled as: 1) ANGIOGRAPHY SPECIALS

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 procedure kits labeled as: 1) ACOUSTIC NEUROMA PACK-LF, Pack Number DYNJ37741B; 2) ANGIOGRAPHY PACK, Pack Number DYNJ21519W; 3) NEURO ANGIO PACK, Pack Number DYNJ83941; 4) NEURO ANGIO PACK SJF-LF, Pack Number DYNJ55678; 5) NEURO PACK, Pack Number DYNJ04851Q; 6) SNI NEURO, Pack Number DYNJ45379D; 7) VP SHUNT PACK, Pack Number DYNJ55558C

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 procedure kits labeled as: 1) ACL ARTHROSCOPY PACK, Pack Number DYNJ55316G; 2) ARTERIOGRAM PACK, Pack Number DYNJ64332; 3) ARTHRO PACK-LF, Pack Number DYNJ38748F; 4) ARTHRO PACK-LF, Pack Number DYNJ38748F; 5) ARTHROGRAM PACK, Pack Number DYNJ65817; 6) ARTHROGRAM TRAY, Pack Number DYNDH1937; 7) ARTHROSCOPY KNEE PACK-LF, Pack Number DYNJ0809731F; 8) ARTHROSCOPY PACK, Pack Number DYNJ66665; 9) ARTHROSCOPY PACK, Pack Number DYNJ38716C; 10) ARTHROSCOPY PACK, Pack Number DYNJ33639J; 11) ARTHROSCOPY PACK, Pack Number DYNJ37707D; 12) ARTHROSCOPY PACK, Pack Number DYNJ38914A; 13) ARTHROSCOPY PACK, Pack Number DYNJ64526A; 14) ARTHROSCOPY PACK, Pack Number DYNJ62755B; 15) ARTHROSCOPY PACK, Pack Number DYNJ61634B; 16) ARTHROSCOPY PACK, Pack Number DYNJ83129; 17) ARTHROSCOPY PACK, Pack Number DYNJ35906F; 18) ARTHROSCOPY PACK, Pack Number DYNJ35906F; 19) ARTHROSCOPY PACK, Pack Number DYNJ37946C; 20) ARTHROSCOPY PACK, Pack Number DYNJ68133A; 21) ARTHROSCOPY PACK BCS, Pack Number DYNJ45629B; 22) ARTHROSCOPY PACK -LF, Pack Number DYNJ0781838S; 23) ARTHROSCOPY PACK-LF, Pack Number DYNJ80469B; 24) ARTHROSCOPY PACK-SHOULDER, Pack Number DYNJ04452L; 25) ARTHROSCOPY PACK-SHOULDER, Pack Number DYNJ24507G; 26) ARTHROSCOPY TRAY, Pack Number DYNJ65948A; 27) ARTHROSCOPY TRAY, Pack Number DYNJ81547; 28) BACK PACK-LF, Pack Number DYNJ0381507N; 29) BASIC ORTHO PACK, Pack Number DYNJ67212A; 30) BASIC SPINE PACK-LF, Pack Number DYNJ39199F; 31) CLOVIS LOWER EXTREMITY-LF, Pack Number DYNJ61066C; 32) CRANIOTOMY PACK, Pack Number DYNJ45145G; 33) CRANIOTOMY PACK-LF, Pack Number DYNJ0530906AO; 34) CRANIOTOMY PACK-LF, Pack Number DYNJ38351O; 35) DL-KNEE SCOPE, Pack Number DYNJ67595B; 36) ENSEMBLE CRANIOTOMIE-LF, Pack Number DYNJ29202D; 37) ESC HAND PACK, Pack Number DYNJ42264; 38) EXTREMITY, Pack Number DYNJ52017; 39) EXTREMITY PACK, Pack Number DYNJ64167D; 40) EXTREMITY PACK, Pack Number DYNJ52104A; 41) EXTREMITY PACK, Pack Number DYNJ53915D; 42) EXTREMITY PACK, Pack Number DYNJ35046B; 43) EXTREMITY PACK, Pack Number DYNJ83732; 44) EXTREMITY PACK, Pack Number DYNJ54684B; 45) EXTREMITY PACK-BELVIDERE, Pack Number DYNJ44692D; 46) EXTREMITY/TRAUMA PACK-LF, Pack Number DYNJ0190688Q; 47) FAIRFIELD KNEE-LF, Pack Number DYNJ30196F; 48) FH PODIATRY PACK-LF, Pack Number DYNJ51796G; 49) FHWC EXTREMITY PACK, Pack Number DYNJ39734D; 50) FOOT AND ANKLE PACK, Pack Number DYNJ65319B; 51) GENERAL ORTHO PACK-LF, Pack Number DYNJ0781892X; 52) GP ARTHROSCOPY KNEE PACK-LF, Pack Number DYNJ0163462Y; 53) GSC KNEE ARTHROSCOPY, Pack Number DYNJ908637; 54) HAND NO SPONGE NOBASIN NOBOWL, Pack Number DYNJ68906; 55) HAND PACK, Pack Number DYNJ44076B; 56) HAND PACK, Pack Number DYNJ60203; 57) HAND PACK, Pack Number DYNJ42329G; 58) HAND PACK, Pack Number DYNJ43386; 59) HAND PACK, Pack Number DYNJ38715C; 60) HAND PACK, Pack Number DYNJ51930A; 61) HAND PACK, Pack Number DYNJ56195C; 62) HAND PACK, Pack Number DYNJ48236I; 63) HAND PACK, Pack Number DYNJ82784; 64) HAND PACK, Pack Number DYNJ55283D; 65) HAND PACK, Pack Number DYNJ44084D; 66) HAND PACK, Pack Number DYNJ46978B; 67) HAND PACK, Pack Number DYNJ81283; 68) HAND PACK, Pack Number DYNJ69908A; 69) HAND PACK XM-LF, Pack Number DYNJ39828D; 70) HAND PACK-LF, Pack Number DYNJ04606G; 71) HAND PACK-LF, Pack Number DYNJ0773815M; 72) HAND PACK-LF, Pack Number DYNJ59960B; 73) HAND/ELBOW PACK, Pack Number DYNJ52097F; 74) HIP PACK, Pack Number DYNJ23762L; 75) HL ACL PACK, Pack Number DYNJ40357C; 76) JOS KNEE PACK, Pack Number PHS977014AK; 77) KNEE ARTH PACK, Pack Number DYNJ83854A; 78) KNEE ARTHROSCOPY, Pack Number DYNJ50313A; 79) KNEE ARTHROSCOPY, Pack Number DYNJ64208; 80) KNEE ARTHROSCOPY PACK, Pack Number DYNJ50682B; 81) KNEE ARTHROSCOPY PACK, Pack Number DYNJ61581A; 82) KNEE ARTHROSCOPY PACK, Pack Number DYNJ41162; 83) KNEE ARTHROSCOPY PACK, Pack Number DYNJ48237J; 84) KNEE ARTHROSCOPY PACK, Pack Number DYNJ39184B; 85) KNEE ARTHROSCOPY PACK, Pack Number D

Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Small Model/Catalog Number: REF# 9524 (Small) Product Description: The Checkpoint Guardian Intraoperative Leads are single-patient disposable accessories for providing stimulus to a targeted nerve. The accessories are intended for use with any device from the Checkpoint Stimulator/Locator Family. The lead electrode is intended to wrap around nerves that have been surgically exposed, allowing the surgeons to provide hands free stimulus to a targeted nerve.

Reason: Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button subassembly, potentially leading to exposed metal. There is a risk of electrical current leakage, which may lead to inconsistent or confusing muscle responses, potentially compromising the effectiveness of the intended use as the surgeon could take an incorrect clinical action.

Root cause: Process control

Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Medium Model/Catalog Number: REF# 9525 (Medium) Product Description: The Checkpoint Guardian Intraoperative Leads are single-patient disposable accessories for providing stimulus to a targeted nerve. The accessories are intended for use with any device from the Checkpoint Stimulator/Locator Family. The lead electrode is intended to wrap around nerves that have been surgically exposed, allowing the surgeons to provide hands free stimulus to a targeted nerve.

Reason: Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button subassembly, potentially leading to exposed metal. There is a risk of electrical current leakage, which may lead to inconsistent or confusing muscle responses, potentially compromising the effectiveness of the intended use as the surgeon could take an incorrect clinical action.

Root cause: Process control

Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or other complications associated with immobility, Product Codes P7520A19, P7520A20S, P7520A21, P7520A22S, P7520A23, P7520A24S, P7520A3, P7520A31, P7520A37, P7520A39, P7520A45, and P7520A4S.

Reason: The air bladders inside the mattress may move out of position when the head of the bed is elevated, causing a dip in the mattress.

Root cause: Nonconforming Material/Component

Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R

Reason: Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula of the device, which could cause respiratory failure, aspiration, unspecified tissue injury, aspiration, respiratory tract infection, bronchospasm, a delay to treatment and/or death.

Root cause: Under Investigation by firm