Recall Z-1448-2025
MEDLINE INDUSTRIES, LP - Northfield · initiated February 11, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ57622; 2) C SECTION PACK, Pack Number DYNJ48483B; 3) C SECTION PACK, Pack Number DYNJ61573; 4) C SECTION PACK, Pack Number DYNJ66801; 5) C SECTION PACK-LF, Pack Number DYNJ0367951P; 6) C SECTION PACK-LF, Pack Number DYNJ55345D; 7) C-SECTION PACK, Pack Number DYNJ04521J; 8) C-SECTION PACK, Pack Number DYNJ32632F; 9) C-SECTION PACK, Pack Number DYNJ65961B; 10) SMJ C-SECTION PACK-LF, Pack Number DYNJ38582J
Codes / lots: 1) Pack Number DYNJ57622: UDI/DI 10889942757244 (each) 40889942757245 (case), Lot Number 20LMF902A; 2) Pack Number DYNJ48483B: UDI/DI 10193489659405 (each) 40193489659406 (case), Lot Number 20CKB746A; 3) Pack Number DYNJ61573: UDI/DI 10193489601077 (each) 40193489601078 (case), Lot Number 22CMB584A; 4) Pack Number DYNJ66801: UDI/DI 10193489384000 (each) 40193489384001 (case), Lot Number 22GBW063A; 5) Pack Number DYNJ0367951P: UDI/DI 10193489966923 (each) 40193489966924 (case), Lot Number 21IMH644A; 6) Pack Number DYNJ55345D: UDI/DI 10195327173722 (each) 40195327173723 (case), Lot Number 22GBJ830A; 7) Pack Number DYNJ04521J: UDI/DI 10193489555837 (each) 40193489555838 (case), Lot Number 21HMA851A; 8) Pack Number DYNJ32632F: UDI/DI 10193489888966 (each) 40193489888967 (case), Lot Number 21IMD959A; 9) Pack Number DYNJ65961B: UDI/DI 10193489984309 (each) 40193489984300 (case), Lot Number 23LMG679A; 10) Pack Number DYNJ38582J: UDI/DI 10193489528244 (each) 40193489528245 (case), Lot Number 21IMF094A
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.
FDA-determined cause: Under Investigation by firm
Action taken
Medline Industries LP issued a recall notice to its consignees on 02/11/2025 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request the syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers. This is an expansion of RES 94583
Details
- Recall number
- Z-1448-2025
- Initiated
- February 11, 2025
- Posted by FDA
- March 25, 2025
- Product code
- OHM – Cesarean Section Tray
- Quantity
- 605 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1435-2025 Class II | Medline procedure kits labeled as: 1) BILATERAL FACET TRAY, Pack Number DYNJRA0869A; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 02/11/2025Open, Classified |
| Z-1436-2025 Class II | Medline procedure kits labeled as: 1) ANGIO PACK, Pack Number DYNJ50624A; 2) ANGIO PACK…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 02/11/2025Open, Classified |
| Z-1437-2025 Class II | Medline procedure kits labeled as: 1) ANGIO DRAPE PACK (DRLUL)-LF, Pack Number…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 02/11/2025Open, Classified |
| Z-1438-2025 Class II | Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ80088; 2) AV…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 02/11/2025Open, Classified |
| Z-1439-2025 Class II | Medline procedure kits labeled as: 1) AV FISTULA PACK-LF, Pack Number DYNJ0826753O; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 02/11/2025Open, Classified |
| Z-1440-2025 Class II | Medline procedure kits labeled as: 1) CT BIOPSY PACK, Pack Number DYNJ62734A; 2) E R C P…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 02/11/2025Open, Classified |
| Z-1441-2025 Class II | Medline procedure kits labeled as: 1) ABLATION PACK, Pack Number DYNJ40629B; 2) ACH…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 02/11/2025Open, Classified |
| Z-1442-2025 Class II | Medline procedure kits labeled as: 1) GENERAL ENDOSCOPY PACK, Pack Number DYNJ44673GMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 02/11/2025Open, Classified |
| Z-1443-2025 Class II | Medline procedure kits labeled as: 1) CV NEONATAL PACK, Pack Number DYNJ67356Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 02/11/2025Open, Classified |
| Z-1444-2025 Class II | Medline procedure kits labeled as: 1) A & A KNEE PACK-LF, Pack Number DYNJHS0136D; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 02/11/2025Open, Classified |
| Z-1445-2025 Class II | Medline procedure kits labeled as: 1) LACERATION TRAY, Pack Number DYNJ17328BMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 02/11/2025Open, Classified |
| Z-1446-2025 Class II | Medline procedure kits labeled as: 1) DELIVERY PACK, Pack Number DYNJ0923016; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 02/11/2025Open, Classified |
| Z-1447-2025 Class II | Medline procedure kits labeled as: 1) CLOVIS ROBOTIC-LF, Pack Number DYNJ61061D; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 02/11/2025Open, Classified |
| Z-1449-2025 Class II | Medline procedure kits labeled as: 1) CSMC/ABDOMINAL HYST PACK-LF, Pack Number…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 02/11/2025Open, Classified |
| Z-1450-2025 Class II | Medline procedure kits labeled as: 1) L S GYN PACK, Pack Number DYNJ65616C; 2) MAIN…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 02/11/2025Open, Classified |
| Z-1451-2025 Class II | Medline procedure kits labeled as: 1) AOP/BASIC EYE PACK-LF, Pack Number DYNJ0589795V…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 02/11/2025Open, Classified |
| Z-1452-2025 Class II | Medline procedure kits labeled as: 1) ARTHROSCOPY PACK, Pack Number DYNJHS0101I; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 02/11/2025Open, Classified |
| Z-1453-2025 Class II | Medline procedure kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Number 613034700, 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 02/11/2025Open, Classified |