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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94585

8 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 08, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
MEDLINE INDUSTRIES, LP - Northfield

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

8 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 8

Centurion procedure kits labeled as: 1) BIOPSY KIT, Pack Number DYNDA1466A; 2) BIOPSY SKIN/LACERATION TRAY, Pack Number SUT20455; 3) CHEST TUBE INSERTION TRAY, Pack Number CHT560; 4) CUSTOM BIOPSY TRAY, Pack Number MNS4815; 5) PERITONSILLAR ABSCESS TRAY, Pack Number MNS3560; 6) PRE POST DIALYSIS, Pack Number DYNDC3274; 7) STEREO PROCEDURE TRAY, Pack Number DYNDC2859A

Z-2766-2024
Recall number
Z-2766-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

DYNDA1466A, Lot Number 2022040190; SUT20455, Lot Number 2022040190; CHT560, Lot Number 2021092290; MNS4815, Lot Number 2022040190; MNS3560, Lot Number 2021021790; MNS3560, Lot Number 2021092290; MNS3560, Lot Number 2021092890; MNS3560, Lot Number 2022040190; MNS3560, Lot Number 2022071490; MNS3560, Lot Number 2023121290; DYNDC3274, Lot Number 2023121290; DYNDC2859A, Lot Number 2021092290

Distribution pattern

worldwide

device · product 2 of 8

Centurion procedure kits, labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C; 2) ARTERIAL LINE TRAY-NO CATHETER, Pack Number ART1170; 3) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220; 4) ARTHROGRAPH TRAY, Pack Number MNS12670A; 5) BIOPSY SKIN/LACERATION TRAY, Pack Number SUT20455; 6) BIOPSY TRAY, Pack Number BT1060; 7) BIOPSY TRAY, Pack Number BT1015; 8) BIOPSY TRAY, Pack Number DYNDH1137C; 9) BIOPSY TRAY-LF, Pack Number SPEC4380; 10) BONE MARROW BIOPSY ASPIRATION, Pack Number DYNJTS0214; 11) BREAST BIOPSY TRAY, Pack Number SPEC0130C; 12) CDP, INTRODUCER KIT 9F, Pack Number S5078BF09; 13) CHEST TUBE INSERTION TRAY, Pack Number CHT560; 14) CIRCUMCISION TRAY, Pack Number CIT7050C; 15) CT BIOPSY TRAY W/CHLORAPREP, Pack Number DYNJ05162; 16) CVC INSERT BUNDLE 16CM, Pack Number ECVC7860; 17) ER CHEST TUBE TRAY, Pack Number CHT1570A; 18) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150; 19) ISHAK I.R. BIOPSY TRAY, Pack Number DYNDH1297; 20) LOCAL INFILTRATION TRAY, Pack Number DYNDH1406; 21) LUMBAR PUNCTURE TRAY, Pack Number PT215; 22) LUMBAR TRAY, Pack Number SPEC0197B; 23) NICU PICC KIT, Pack Number CVI4575; 24) OB DELIVERY TRAY, Pack Number MNS10875A; 25) ON/OFF KIT, Pack Number DT8525; 26) PEDI ULTRASOUND GUIDED PIV KIT, Pack Number IVS3320; 27) PERIPHERAL BLOOD CULTURE KIT (1 SET), Pack Number DYNDH1910; 28) PERITONSILLAR ABSCESS TRAY, Pack Number MNS3560; 29) PORT ACCESS KIT, Pack Number DYNDC2945; 30) PORT ACCESS TRAY, Pack Number EBSI1241; 31) PORT INSERTION KIT, Pack Number MNS11590; 32) STEREO PROCEDURE TRAY, Pack Number DYNDC2859A; 33) STEREOTACTIC TRAY, Pack Number MNS5785; 34) SUTURING SET, Pack Number SUT4020; 35) U.A.C. TRAY, Pack Number UVT125; 36) ULTRASOUND TRAY, Pack Number MNS5460; 37) UMBILICAL VES CATH INSERT TRAY, Pack Number UVT1080; 38) UMBILICAL VESSEL TRAY, Pack Number UVT1100A; 39) VAGINAL DELIVERY TRAY, Pack Number MNS11020A

Z-2767-2024
Recall number
Z-2767-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

ART245C, Lot Number 2023101990; ART1170, Lot Number 2022121990; ART1170, Lot Number 2023012790; ART1170, Lot Number 2023021590; PT220, Lot Number 2021061490; PT220, Lot Number 2022011090; MNS12670A, Lot Number 2021060190; MNS12670A, Lot Number 2022011090; MNS12670A, Lot Number 2023022190; MNS12670A, Lot Number 2023101890; SUT20455, Lot Number 2021060190; SUT20455, Lot Number 2022011090; SUT20455, Lot Number 2023012390; BT1060, Lot Number 2020062490; BT1015, Lot Number 2021060190; DYNDH1137C, Lot Number 2021091490; DYNDH1137C, Lot Number 2022121990; SPEC4380, Lot Number 2018102950; SPEC4380, Lot Number 2023032390; DYNJTS0214, Lot Number 2022061790; DYNJTS0214, Lot Number 22121990; SPEC0130C, Lot Number 2023022190; S5078BF09, Lot Number 2020051850; S5078BF09, Lot Number 2022092290; CHT560, Lot Number 2018042790; CHT560, Lot Number 2018050790; CHT560, Lot Number 2018060490; CHT560, Lot Number 2018080790; CHT560, Lot Number 2018091190; CHT560, Lot Number 2020032490; CHT560, Lot Number 2020051990; CHT560, Lot Number 2020062490; CHT560, Lot Number 2020070190; CHT560, Lot Number 2020071490; CHT560, Lot Number 2020121590; CHT560, Lot Number 2021042690; CHT560, Lot Number 2021082390; CHT560, Lot Number 2021091490; CHT560, Lot Number 2022022490; CHT560, Lot Number 2022050490; CIT7050C, Lot Number 2023081480; CIT7050C, Lot Number 2023101680; CIT7050C, Lot Number 2024010590; DYNJ05162, Lot Number 2020082050; ECVC7860, Lot Number 2023101990; CHT1570A, Lot Number 2021051290; MNS12150, Lot Number 2019082790; MNS12150, Lot Number 2020021290; MNS12150, Lot Number 2020060290; MNS12150, Lot Number 2020101390; MNS12150, Lot Number 2020111790; MNS12150, Lot Number 2020121890; MNS12150, Lot Number 2021051290; MNS12150, Lot Number 2021071390; MNS12150, Lot Number 2022012890; MNS12150, Lot Number 2022061790; MNS12150, Lot Number 2022092290; MNS12150, Lot Number 2023010690; MNS12150, Lot Number 2023030690; MNS12150, Lot Number 2023082490; DYNDH1297, Lot Number 2019091750; DYNDH1406, Lot Number 2023102790; PT215, Lot Number 2018050350; PT215, Lot Number 2018100950; PT215, Lot Number 2018102950; PT215, Lot Number 2019091750; PT215, Lot Number 2019100450; PT215, Lot Number 2020051850; PT215, Lot Number 2020082050; PT215, Lot Number 2020102850; PT215, Lot Number 2020121550; PT215, Lot Number 2021021850; PT215, Lot Number 2021111850; PT215, Lot Number 2022021650; PT215, Lot Number 2022043050; PT215, Lot Number 2022072990; PT215, Lot Number 2023012390; PT215, Lot Number 2023032790; PT215, Lot Number 2023102790; PT215, Lot Number 2023122090; SPEC0197B, Lot Number 2018102950; CVI4575, Lot Number 2023102590; CVI4575, Lot Number 2023120190; MNS10875A, Lot Number 2021060190; DT8525, Lot Number 2023070590; DT8525, Lot Number 2023092890; DT8525, Lot Number 2024022090; IVS3320, Lot Number 2021061490; DYNDH1910, Lot Number 2023120480; MNS3560, Lot Number 2021091490; DYNDC2945, Lot Number 2023062190; EBSI1241, Lot Number 2021051290; MNS11590, Lot Number 2019072590; MNS11590, Lot Number 2021010690; MNS11590, Lot Number 2021061490; MNS11590, Lot Number 2021122190; MNS11590, Lot Number 2022050490; MNS11590, Lot Number 2023032390; MNS11590, Lot Number 2023062190; MNS11590, Lot Number 2023101990; DYNDC2859A, Lot Number 2021082390; MNS5785, Lot Number 2023032290; MNS5785, Lot Number 2023090590; MNS5785, Lot Number 2023120790; MNS5785, Lot Number 2024030690; SUT4020, Lot Number 2020051990; SUT4020, Lot Number 2020062490; UVT125, Lot Number 2021082390; MNS5460, Lot Number 2020051990; UVT1080, Lot Number 2022121990; UVT1080, Lot Number 2023090590; UVT1100A, Lot Number 2022050280; UVT1100A, Lot Number 2023011680; UVT1100A, Lot Number 2023041780; UVT1100A, Lot Number 2023061980; UVT1100A, Lot Number 2023101680; UVT1100A, Lot Number 2023120480; UVT1100A, Lot Number 2024011580; MNS11020A, Lot Number 2021060190

Distribution pattern

worldwide

device · product 3 of 8

Centurion procedure kits labeled as: 1) 3" RADIAL ARTERIAL LINE KIT- ICU, Pack Number ART240B; 2) 5FR 2L PICC LINE TRAY, Pack Number PICC0020; 3) 6" FEMORAL ARTERIAL LINE KIT, Pack Number ART245B; 4) ADVANCED REPAIR KIT, Pack Number SUT15940; 5) ARTHROGRAM TRAY, Pack Number SPEC0004C; 6) ARTHROGRAM TRAY, Pack Number DYNDH1134; 7) ARTHROGRAM TRAY-LF, Pack Number SPEC0400; 8) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220; 9) AULTMAN HOSPITAL CHEST TUBE INSERTION TR, Pack Number CHT500; 10) BIOPSY BASIC PACK, Pack Number P784604; 11) BIOPSY KIT, Pack Number DYNDA1466A; 12) BIOPSY SKIN/LACERATION TRAY, Pack Number SUT20455; 13) BIOPSY TRAY, Pack Number BT1015; 14) BIOPSY TRAY, Pack Number DYNDH1273; 15) BIOPSY TRAY, Pack Number BT1060; 16) BIOPSY TRAY, Pack Number DYNDH1340; 17) BIOPSY TRAY, Pack Number P151659; 18) BIOPSY TRAY, Pack Number SPEC0292; 19) BIOPSY TRAY, Pack Number DYNDH1314A; 20) BIOPSY TRAY, Pack Number DYNDH1137C; 21) BIOPSY TRAY - LF, Pack Number DYNJTS0018A; 22) BIOPSY TRAY-LF, Pack Number SPEC4380; 23) BIOPSY/ARTHROGRAM TRAY, Pack Number DYNDH1115; 24) BONE MARROW BIOPSY ASPIRATION, Pack Number DYNJTS0214; 25) BREAST BIOPSY TRAY, Pack Number SPEC0130C; 26) CATHETER ON/OFF KIT, Pack Number DT5490B; 27) CDP, INTRODUCER KIT 9F, Pack Number S5078BF09; 28) CHEST TUBE INSERTION TRAY, Pack Number CHT705; 29) CHEST TUBE INSERTION TRAY, Pack Number CHT1900; 30) CHEST TUBE, UMBI LINE PK, Pack Number DYNDA1432A; 31) CIRCUMCISION TRAY, Pack Number CIT6260; 32) CIRCUMCISION/MINOR TRAY, Pack Number CIT6785A; 33) CONGENITAL ADD-ON KIT, Pack Number DYNDA2213A; 34) CORE BIOPSY TRAY, Pack Number SPEC0083B; 35) CT BIOPSY TRAY W/CHLORAPREP, Pack Number DYNJ05162; 36) CUSTOM BIOPSY TRAY, Pack Number MNS4815; 37) CUSTOM BX TRAY, Pack Number SPEC0071B; 38) DELIVERY ACCESSORY KIT, Pack Number MNS6496; 39) DIAGNOSTIC TRAY, Pack Number DYNDH1359; 40) E. R. LACERATION TRAY, Pack Number DYNDL1187A; 41) ER CHEST TUBE TRAY, Pack Number CHT1570A; 42) ER LACERATION TRAY C WEST, Pack Number DYNDL2952; 43) FACET BLOCK TRAY-AVERY MELVIN, Pack Number DYNJRA0421; 44) FINE LACERATION KIT, Pack Number SUT19360; 45) FINE LACERATION KIT, Pack Number SUT17215; 46) HH PACK BIOPSY, Pack Number BT345; 47) HSG TRAY, Pack Number DYNDH1453; 48) I&D TRAY, Pack Number ID2165; 49) INCISION & DRAINAGE TRAY, Pack Number ID2060; 50) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645; 51) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150; 52) ISHAK I.R. BIOPSY TRAY, Pack Number DYNDH1297; 53) LACERATION TRAY, Pack Number SUT20955; 54) LACERATION TRAY, Pack Number DYNDL1772; 55) LACERATION TRAY, Pack Number DYNDL1250C; 56) LACERATION TRAY, Pack Number DYNDL1887; 57) LACERATION TRAY, Pack Number SUT3780; 58) LACERATION TRAY, Pack Number DYNDL1774A; 59) LACERATION TRAY, Pack Number SUT18080; 60) LACERATION TRAY, Pack Number SUT21490; 61) LOCAL INFILTRATION TRAY, Pack Number DYNDH1406; 62) LUMBAR EPIDURAL TRAY-LF, Pack Number DYNJRA0313B; 63) LUMBAR PUNCTURE TRAY, Pack Number DYNDH1321; 64) LUMBAR PUNCTURE TRAY, Pack Number SPEC0289; 65) LUMBAR PUNCTURE TRAY, Pack Number PT215; 66) LUMBAR TRAY, Pack Number SPEC0177; 67) LUMBAR TRAY, Pack Number DYNDH1540A; 68) MAMMOGRAPHY BIOPSY TRAY, Pack Number DYNDH1304A; 69) MINI INTERVENTIONAL PACK, Pack Number DYNDH1324; 70) MYELO / ARTHRO TRAY, Pack Number DYNDH1332A; 71) MYELOGRAM TRAY, Pack Number DYNJTS0516A; 72) MYELOGRAM TRAY, Pack Number DYNJTS0514; 73) MYELOGRAM TRAY, Pack Number DYNDH1531; 74) OB DELIVERY SET, Pack Number MNS3355; 75) OB DELIVERY TRAY, Pack Number MNS5575; 76) OHS CT BIOPSY TRAY -LF, Pack Number DYNDH1270; 77) ONCOLOGY-HEMOTOLOGY PREP TRAY-STERILE/LF, Pack Number DYNDA2523; 78) PACEMAKER TRAY, Pack Number MNS12700; 79) PACEMAKER TRAY, Pack Number MNS12625; 80) PACEMAKER TRAY, Pack Number MNS12700A; 81) PACK,CHALAZION SEY59CHCHA, Pack Number DYNDL1571B; 82) PEDI ULTRASOUND GUIDED PIV KIT, Pack Number IVS3320; 83)

Z-2768-2024
Recall number
Z-2768-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

ART240B, Lot Number 2023083190; PICC0020, Lot Number 2023122290; ART245B, Lot Number 2023020990; ART245B, Lot Number 2023071090; SUT15940, Lot Number 2021070290; SUT15940, Lot Number 2022090190; SUT15940, Lot Number 2022092690; SPEC0004C, Lot Number 2019042990; DYNDH1134, Lot Number 2020032050; SPEC0400, Lot Number 2021120990; SPEC0400, Lot Number 2022090190; SPEC0400, Lot Number 2023050390; PT220, Lot Number 2018082290; PT220, Lot Number 2020040890; PT220, Lot Number 2020051490; PT220, Lot Number 2020061090; PT220, Lot Number 2020071590; PT220, Lot Number 2020122190; PT220, Lot Number 2021040790; PT220, Lot Number 2021050390; PT220, Lot Number 2021080690; PT220, Lot Number 2021082790; PT220, Lot Number 2021100690; PT220, Lot Number 2022082490; PT220, Lot Number 2023030290; PT220, Lot Number 2023110690; PT220, Lot Number 2023122290; PT220, Lot Number 2024031190; CHT500, Lot Number 2021113090; CHT500, Lot Number 2021121690; CHT500, Lot Number 2022050390; CHT500, Lot Number 2023060190; CHT500, Lot Number 2023070390; CHT500, Lot Number 2023092290; P784604, Lot Number 2019081980; DYNDA1466A, Lot Number 2022092690; SUT20455, Lot Number 2018090690; SUT20455, Lot Number 2019022590; SUT20455, Lot Number 2019042990; SUT20455, Lot Number 2019101690; SUT20455, Lot Number 2019112590; SUT20455, Lot Number 2020040690; SUT20455, Lot Number 2021042190; SUT20455, Lot Number 2021062590; SUT20455, Lot Number 2021081090; SUT20455, Lot Number 2022070590; SUT20455, Lot Number 2023070590; SUT20455, Lot Number 2023100590; SUT20455, Lot Number 2023122990; BT1015, Lot Number 2019013190; DYNDH1273, Lot Number 2019080190; BT1060, Lot Number 2019091090; DYNDH1340, Lot Number 2019100190; BT1060, Lot Number 2019103190; P151659, Lot Number 2019112590; DYNDH1340, Lot Number 2019121290; SPEC0292, Lot Number 2020012290; BT1015, Lot Number 2020082490; BT1060, Lot Number 2020082890; DYNDH1314A, Lot Number 2020100901; BT1015, Lot Number 2020102990; DYNDH1137C, Lot Number 2020102990; BT1015, Lot Number 2021010590; BT1015, Lot Number 2021032590; BT1015, Lot Number 2021050390; BT1015, Lot Number 2021070690; BT1015, Lot Number 2021100490; BT1015, Lot Number 2022021890; BT1015, Lot Number 2022102490; BT1015, Lot Number 2023013090; BT1015, Lot Number 2023040490; BT1015, Lot Number 2023060990; DYNJTS0018A, Lot Number 2020010850; DYNJTS0018A, Lot Number 2022050390; SPEC4380, Lot Number 2021120990; SPEC4380, Lot Number 2022032290; SPEC4380, Lot Number 2022060890; DYNDH1115, Lot Number 2019080190; DYNJTS0214, Lot Number 2022051790; DYNJTS0214, Lot Number 2023112890; SPEC0130C, Lot Number 2020082490; SPEC0130C, Lot Number 2021102790; DT5490B, Lot Number 2022121490; S5078BF09, Lot Number 2021031650; CHT705, Lot Number 2019121290; CHT705, Lot Number 2019121990; CHT705, Lot Number 2020021890; CHT705, Lot Number 2020040690; CHT705, Lot Number 2021080690; CHT1900, Lot Number 2022040590; CHT705, Lot Number 2022092690; CHT1900, Lot Number 2022110890; DYNDA1432A, Lot Number 2019100190; CIT6260, Lot Number 2020100901; CIT6260, Lot Number 2022011190; CIT6260, Lot Number 2022060890; CIT6260, Lot Number 2022072290; CIT6785A, Lot Number 2020081090; CIT6785A, Lot Number 2021022390; CIT6785A, Lot Number 2021032590; DYNDA2213A, Lot Number 2019081980; SPEC0083B, Lot Number 2022072190; SPEC0083B, Lot Number 2023050390; DYNJ05162, Lot Number 2022022390; MNS4815, Lot Number 2021100590; MNS4815, Lot Number 2021122890; MNS4815, Lot Number 2023011390; MNS4815, Lot Number 2023012090; MNS4815, Lot Number 2023061590; SPEC0071B, Lot Number 2019022590; MNS6496, Lot Number 2019022590; MNS6496, Lot Number 2023062990; DYNDH1359, Lot Number 2019022590; DYNDH1359, Lot Number 2019040290; DYNDH1359, Lot Number 2019100190; DYNDH1359, Lot Number 2020072290; DYNDH1359, Lot Number 2020091490; DYNDH1359, Lot Number 2021021990; DYNDH1359, Lot Number 2021031290; DYNDH1359, Lot Number 2021042290; DYNDH1359, Lot Number 2021060490; DYNDH1359, Lot Number 2021070690; DYNDH1359, Lot Number 2022041890; DYNDH1359, Lot Number 2022051790; DYNDH1359, Lot Number 2022062990; DYNDH1359, Lot Number 2023050390; DYNDH1359, Lot Number 2023061990; DYNDL1187A, Lot Number 2019121290; CHT1570A, Lot Number 2021121690; CHT1570A, Lot Number 2022032290; CHT1570A, Lot Number 2023060190; CHT1570A, Lot Number 2023070390; DYNDL2952, Lot Number 2022030990; DYNDL2952, Lot Number 2022062290; DYNJRA0421, Lot Number 2019100190; DYNJRA0421, Lot Number 2020010690; SUT19360, Lot Number 2020070750; SUT19360, Lot Number 2022062990; SUT19360, Lot Number 2022091490; SUT19360, Lot Number 2023030290; SUT19360, Lot Number 2023062990; SUT19360, Lot Number 2023081490; SUT17215, Lot Number 2018110580; SUT17215, Lot Number 2019030480; SUT17215, Lot Number 2019081380; SUT17215, Lot Number 2019123080; SUT17215, Lot Number 2020091480; SUT17215, Lot Number 2020102680; SUT17215, Lot Number 2021011880; SUT17215, Lot Number 2021032980; SUT17215, Lot Number 2021060780; SUT17215, Lot Number 2021102580; BT345, Lot Number 2018071790; BT345, Lot Number 2018080890; DYNDH1453, Lot Number 2019080190; ID2165, Lot Number 2020042090; ID2165, Lot Number 2022101990; ID2165, Lot Number 2022102690; ID2165, Lot Number 2022111890; ID2060, Lot Number 2022090190; ID2060, Lot Number 2023010590; ID2060, Lot Number 2023041490; ID2060, Lot Number 2023080390; ID2060, Lot Number 2023101190; ID2060, Lot Number 2024030190; DM645, Lot Number 2020091480; MNS12150, Lot Number 2021031090; MNS12150, Lot Number 2021092490; MNS12150, Lot Number 2023071090; DYNDH1297, Lot Number 2022051650; SUT20955, Lot Number 2018082990; SUT20955, Lot Number 2018100290; DYNDL1772, Lot Number 2019022590; SUT20955, Lot Number 2019042690; DYNDL1250C, Lot Number 2019080190; DYNDL1887, Lot Number 2019080190; SUT3780, Lot Number 2019091790; DYNDL1774A, Lot Number 2019091790; SUT20955, Lot Number 2019110890; SUT18080, Lot Number 2020010850; SUT18080, Lot Number 2020032050; SUT3780, Lot Number 2020032790; SUT20955, Lot Number 2020041390; SUT21490, Lot Number 2020042090; SUT18080, Lot Number 2020063050; SUT20955, Lot Number 2020070790; SUT3780, Lot Number 2020082590; SUT20955, Lot Number 2020101690; SUT3780, Lot Number 2021020890; SUT20955, Lot Number 2021031090; SUT18080, Lot Number 2021031650; SUT18080, Lot Number 2021052750; SUT20955, Lot Number 2021070690; SUT18080, Lot Number 2021081650; SUT20955, Lot Number 2021082790; SUT20955, Lot Number 2021102690; SUT20955, Lot Number 2021113090; SUT20955, Lot Number 2022030990; SUT18080, Lot Number 2022042750; SUT18080, Lot Number 2022051650; SUT20955, Lot Number 2022060890; SUT18080, Lot Number 2022070550; SUT21490, Lot Number 2022092690; SUT21490, Lot Number 2022110790; SUT21490, Lot Number 2022111890; SUT20955, Lot Number 2022121490; SUT20955, Lot Number 2023042890; SUT20955, Lot Number 2023112890; DYNDH1406, Lot Number 2020010850; DYNDH1406, Lot Number 2021120990; DYNJRA0313B, Lot Number 2019042990; DYNDH1321, Lot Number 2019042990; DYNDH1321, Lot Number 2020010690; SPEC0289, Lot Number 2020010690; PT215, Lot Number 2023070390; SPEC0177, Lot Number 2021102790; DYNDH1540A, Lot Number 2022040590; DYNDH1540A, Lot Number 2022101990; DYNDH1304A, Lot Number 2020012290; DYNDH1324, Lot Number 2020010850; DYNDH1332A, Lot Number 2022111890; DYNJTS0516A, Lot Number 2019112090; DYNJTS0514, Lot Number 2021031650; DYNDH1531, Lot Number 2021051390; MNS3355, Lot Number 2021050390; MNS5575, Lot Number 2019080190; MNS5575, Lot Number 2020032390; MNS5575, Lot Number 2020042090; MNS5575, Lot Number 2020082890; DYNDH1270, Lot Number 2019013190; DYNDA2523, Lot Number 2022122190; MNS12700, Lot Number 2020012290; MNS12625, Lot Number 2020021790; MNS12700, Lot Number 2020022490; MNS12700A, Lot Number 2020081090; MNS12625, Lot Number 2022072190; MNS12700, Lot Number 2023012490; MNS12700, Lot Number 2023060190; DYNDL1571B, Lot Number 2019112590; IVS3320, Lot Number 2020011090; IVS3320, Lot Number 2020091490; IVS3320, Lot Number 2021032590; IVS3320, Lot Number 2021102790; IVS3320, Lot Number 2022121490; IVS3320, Lot Number 2023032990; IVS3320, Lot Number 2023052590; IVS3320, Lot Number 2023072590; IVS3320, Lot Number 2023080490; IVS3320, Lot Number 2023082190; CVI4960, Lot Number 2023070590; DYNDA1732A, Lot Number 2019101690; DYNDC1960A, Lot Number 2023011390; DYNDC2945, Lot Number 2020032390; DYNDC2945, Lot Number 2020051490; DYNDC2945, Lot Number 2021060790; EBSI1241, Lot Number 2020021890; EBSI1241, Lot Number 2021070290; EBSI1241, Lot Number 2023060990; EBSI1241, Lot Number 2023122290; MNS11590, Lot Number 2021032590; MNS11590, Lot Number 2021050390; SPEC0251, Lot Number 2020010850; DYNDC3274, Lot Number 2023013090; SPEC0222A, Lot Number 2020070750; SPEC0222A, Lot Number 2022032290; SPEC0127, Lot Number 2019123080; SPEC0149, Lot Number 2023011390; DYNDA2725, Lot Number 2021102790; DYNDC2859A, Lot Number 2021113090; DYNDC2859A, Lot Number 2022101990; DYNDC2859A, Lot Number 2022111890; DYNDC2859A, Lot Number 2023012690; DYNDC2859A, Lot Number 2023083190; BT1095, Lot Number 2020010690; DYNDA2495, Lot Number 2023092290; SUT14745A, Lot Number 2022121390; SUT14745A, Lot Number 2023032390; SUT14745A, Lot Number 2023060190; SUT14745A, Lot Number 2023092290; SUT14745A, Lot Number 2023120690; SUT14745A, Lot Number 2024020890; MNS6465, Lot Number 2019040190; MNS6465, Lot Number 2020010690; MNS6465, Lot Number 2021051390; MNS6465, Lot Number 2021081090; MNS6465, Lot Number 2021090790; MNS6465, Lot Number 2021100590; MNS6465, Lot Number 2023060190; SUT15695, Lot Number 2021070290; SUT15695, Lot Number 2022011290; SUT15695, Lot Number 2022022390; SUT15695, Lot Number 2022122190; SUT15695, Lot Number 2023050390; SUT15695, Lot Number 2023083190; SUT9975, Lot Number 2023042090; SUT9975, Lot Number 2023051790; SUT9975, Lot Number 2023062890; SUT9975, Lot Number 2023100690; SUT9790, Lot Number 2019121990; SUT9790, Lot Number 2020011090; SUT4020, Lot Number 2020041690; SUT9790, Lot Number 2020061890; SUT4020, Lot Number 2020091190; SUT4020, Lot Number 2020110490; SUT9790, Lot Number 2020112490; SUT4020, Lot Number 2020122990; SUT9790, Lot Number 2021012290; SUT4020, Lot Number 2021022390; SUT4020, Lot Number 2021041490; SUT4020, Lot Number 2021060790; SUT4020, Lot Number 2021070890; SUT4020, Lot Number 2021092490; SUT4020, Lot Number 2022011890; SUT4020, Lot Number 2022041890; SUT4020, Lot Number 2022062290; SUT4020, Lot Number 2022091290; SUT4020, Lot Number 2022121590; SUT4020, Lot Number 2023070590; UVT125, Lot Number 2019061990; UVT125, Lot Number 2019080190; UVT125, Lot Number 2023070690; UVT125, Lot Number 2023083190; MNS9580, Lot Number 2021120990; MNS9580, Lot Number 2022062490; MNS9580, Lot Number 2022091490; MNS9580, Lot Number 2022111890; MNS9580, Lot Number 2023012690; MNS9580, Lot Number 2023022790; MNS9580, Lot Number 2023042090; MNS9580, Lot Number 2023071090; MNS9580, Lot Number 2023081090; MNS9580, Lot Number 2023102590; MNS5460, Lot Number 2019112090; MNS5460, Lot Number 2020032390; MNS5460, Lot Number 2020070790; UVT1080, Lot Number 2023061990; UVT685, Lot Number 2019012180; UVT685, Lot Number 2019042280; UVT685, Lot Number 2019081980; UVT685, Lot Number 2020011380; UVT685, Lot Number 2021120680; UVT685, Lot Number 2022071180; MNS11020A, Lot Number 2020081090; MNS11020A, Lot Number 2021100490

Distribution pattern

worldwide

device · product 4 of 8

Centurion procedure kits labeled as: UMBILICAL VESSEL TRAY, Pack Number UVT1100

Z-2769-2024
Recall number
Z-2769-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

UVT1100, Lot Number 2021032280; UVT1100, Lot Number 2021072680; UVT1100, Lot Number 2021092780; UVT1100, Lot Number 2022011080

Distribution pattern

worldwide

device · product 5 of 8

Centurion procedure kits labeled as: 1) BONE MARROW TRAY, Pack Number SPEC0255; 2) CT/ULTRASOUND BIOPSY, Pack Number SPEC0262; 3) FINE LACERATION KIT, Pack Number SUT17215; 4) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645; 5) LACERATION TRAY, Pack Number DYNDL1159B; 6) SUTURE TRAY, Pack Number DYNDS1064B

Z-2770-2024
Recall number
Z-2770-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

SPEC0255, Lot Number 2020042080: SPEC0262, Lot Number 2018111280: SUT17215, Lot Number 2020042080: DM645, Lot Number 2018111280: DM645, Lot Number 2020042080: DM645, Lot Number 2022020780: DYNDL1159B, Lot Number 2018111280: DYNDS1064B, Lot Number 2020042080

Distribution pattern

worldwide

device · product 6 of 8

Centurion procedure kits, labeled as: 1) BREAST BIOPSY KIT, Pack Number MNS6950A; 2) BREAST BIOPSY PACK, Pack number BT515A

Z-2771-2024
Recall number
Z-2771-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

MNS6950A, Lot Number 2018101150; MNS6950A, Lot Number 2019022550; MNS6950A, Lot Number 2019040350; BT515A, Lot Number 2020040990; BT515A, Lot Number 2021062990; BT515A, Lot Number 2022012090; BT515A, Lot Number 2022022890; BT515A, Lot Number 2022072990; BT515A, Lot Number 2022103190; BT515A, Lot Number 2023031790; BT515A, Lot Number 2023032890; BT515A, Lot Number 2023072590; BT515A, Lot Number 2024022990;

Distribution pattern

worldwide

device · product 7 of 8

Centurion procedure kits, labeled as: 1) ARTHROGRAM TRAY, Pack Number DYNDH1349; 2) ARTHROGRAM TRAY-LF, Pack Number SPEC0400; 3) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220; 4) BIOPSY KIT, Pack Number DYNDH1570; 5) BIOPSY TRAY-LF, Pack Number SPEC4380; 6) BMA BX TRAY, Pack Number DYNDH1050A; 7) BREAST BIOPSY TRAY, Pack Number SPEC0130C; 8) CATHETER ON/OFF KIT, Pack Number DT5490B; 9) CDP, INTRODUCER KIT 9F, Pack Number S5078BF09; 10) CHEST TUBE INSERTION TRAY, Pack Number CHT705; 11) CIRCUMCISION TRAY, Pack Number CIT6260; 12) CUSTOM BIOPSY TRAY, Pack Number MNS4815; 13) DELIVERY ACCESSORY KIT, Pack Number MNS6496; 14) DELIVERY PACK, Pack Number MNS2925A; 15) DELIVERY PACK, Pack Number MNS2925B; 16) E. R. LACERATION TRAY, Pack Number DYNDL1187A; 17) FINE LACERATION KIT, Pack Number SUT19360; 18) GENERAL BIOPSY TRAY- LF, Pack Number SPEC0248B; 19) GENERAL UTILITY, Pack Number DYNDA2524; 20) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227A; 21) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227B; 22) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150; 23) LACERATION TRAY, Pack Number DYNDL1757; 24) MYELOGRAM TRAY, Pack Number DYNDH1531; 25) OB DELIVERY SET, Pack Number MNS3355; 26) OB DELIVERY TRAY, Pack Number MNS10875; 27) OB DELIVERY TRAY, Pack Number MNS5575; 28) OB DELIVERY TRAY, Pack Number MNS10875A; 29) PICU LINE TRAY, Pack Number DYNDC1960A; 30) PORT ACCESS KIT, Pack Number DYNDC2945; 31) PORT ACCESS TRAY, Pack Number EBSI1241; 32) SINGLE TAP BLOCK TRAY, Pack Number SPEC0156A; 33) STEREO PROCEDURE TRAY, Pack Number DYNDC2859A; 34) SUTURING SET, Pack Number SUT9790; 35) SUTURING SET, Pack Number SUT4020; 36) TRAY,GENERAL UTILITY, Pack Number DYNDL1422A; 37) U.A.C. TRAY, Pack Number UVT125; 38) ULTRASOUND GUIDED PIV KIT, Pack Number MNS9580; 39) VAGINAL DELIVERY TRAY, Pack Number MNS11020; 40) VAGINAL DELIVERY TRAY, Pack Number MNS11020A

Z-2772-2024
Recall number
Z-2772-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

DYNDH1349, Lot Number 2019061090; SPEC0400, Lot Number 2022010790; SPEC0400, Lot Number 2022061490; PT220, Lot Number 2020090390; DYNDH1570, Lot Number 2023091390; SPEC4380, Lot Number 2023110890; DYNDH1050A, Lot Number 2019100490; SPEC0130C, Lot Number 2020072090; DT5490B, Lot Number 2022091590; S5078BF09, Lot Number 2022122390; CHT705, Lot Number 2021072990; CIT6260, Lot Number 2022031190; MNS4815, Lot Number 2022042890; MNS6496, Lot Number 2018112690; MNS6496, Lot Number 2019061390; MNS6496, Lot Number 2020040190; MNS6496, Lot Number 2020062290; MNS6496, Lot Number 2020090290; MNS6496, Lot Number 2021072990; MNS6496, Lot Number 2022010790; MNS6496, Lot Number 2022080890; MNS6496, Lot Number 2022122390; MNS6496, Lot Number 2023040690; MNS2925A, Lot Number 2019080690; MNS2925A, Lot Number 2019101190; MNS2925B, Lot Number 2020032090; MNS2925B, Lot Number 2020071690; DYNDL1187A, Lot Number 2019080590; DYNDL1187A, Lot Number 2019100490; SUT19360, Lot Number 2023021090; SPEC0248B, Lot Number 2019041790; DYNDA2524, Lot Number 2019100490; DYNDH1227A, Lot Number 2019061090; DYNDH1227B, Lot Number 2019100490; MNS12150, Lot Number 2021072990; MNS12150, Lot Number 2022031190; DYNDL1757, Lot Number 2019061090; DYNDH1531, Lot Number 2023021090; MNS3355, Lot Number 2019080590; MNS3355, Lot Number 2019100490; MNS3355, Lot Number 2020050890; MNS3355, Lot Number 2020091090; MNS3355, Lot Number 2020113090; MNS3355, Lot Number 2021030890; MNS3355, Lot Number 2021040990; MNS3355, Lot Number 2021052890; MNS3355, Lot Number 2021071590; MNS3355, Lot Number 2021080990; MNS3355, Lot Number 2021122390; MNS3355, Lot Number 2022030790; MNS3355, Lot Number 2022071590; MNS3355, Lot Number 2022080590; MNS3355, Lot Number 2022101490; MNS3355, Lot Number 2023021090; MNS3355, Lot Number 2023053090; MNS3355, Lot Number 2023091390; MNS3355, Lot Number 2023121490; MNS10875, Lot Number 2019031590; MNS5575, Lot Number 2019061090; MNS5575, Lot Number 2020072090; MNS5575, Lot Number 2020081790; MNS10875A, Lot Number 2020081790; MNS10875A, Lot Number 2020090390; MNS5575, Lot Number 2020102390; MNS5575, Lot Number 2021012590; MNS10875A, Lot Number 2021012690; MNS10875A, Lot Number 2021031190; MNS10875A, Lot Number 2021051490; MNS10875A, Lot Number 2021072990; MNS10875A, Lot Number 2021102890; MNS10875A, Lot Number 2022031190; MNS10875A, Lot Number 2022061490; MNS10875A, Lot Number 2022091590; MNS10875A, Lot Number 2023040690; MNS10875A, Lot Number 2023092990; MNS10875A, Lot Number 2023110890; DYNDC1960A, Lot Number 2022010790; DYNDC2945, Lot Number 2023040690; EBSI1241, Lot Number 2021021190; SPEC0156A, Lot Number 2019100490; DYNDC2859A, Lot Number 2020081790; DYNDC2859A, Lot Number 2023053090; SUT9790, Lot Number 2020090390; SUT9790, Lot Number 2020113090; SUT4020, Lot Number 2021051490; SUT4020, Lot Number 2021072990; SUT4020, Lot Number 2022071590; DYNDL1422A, Lot Number 2019061090; UVT125, Lot Number 2023110890; MNS9580, Lot Number 2019100490; MNS9580, Lot Number 2022042890; MNS11020, Lot Number 2018103190; MNS11020, Lot Number 2019012390; MNS11020, Lot Number 2019041790; MNS11020A, Lot Number 2019080690; MNS11020A, Lot Number 2021021190; MNS11020A, Lot Number 2021030390; MNS11020A, Lot Number 2021041690; MNS11020A, Lot Number 2022042890

Distribution pattern

worldwide

device · product 8 of 8

Centurion procedure packs, labeled as: 1) BIOPSY TRAY-LF, Pack Number SPEC4380; 2) CIRCUMCISION TRAY, Pack Number CIT6325; 3) CIRCUMCISION/MINOR TRAY, Pack Number CIT6785A; 4) LUMBAR PUNCTURE TRAY, Pack Number PT215; 5) ULTRASOUND GUIDED PIV KIT, Pack Number MNS9580; 6) VANTEX 7FR 3L 16CM CVC BUNDLE US, Pack Number ECVC8050

Z-2773-2024
Recall number
Z-2773-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

SPEC4380, Lot Number 2023092590; CIT6325, Lot Number 2023082990; CIT6785A, Lot Number 2022120190; CIT6785A, Lot Number 2023021790; CIT6785A, Lot Number 2023041290; CIT6785A, Lot Number 2023092590; PT215, Lot Number 2023082990; MNS9580, Lot Number 2023082990; ECVC8050, Lot Number 2023082990

Distribution pattern

worldwide