—#212688

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

FDA product code: OHM — Cesarean Section Tray
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
Affected lot / code info: 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

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the country of Canada.

Timeline

Recall initiated: 2025-02-11
Posted by FDA: 2025-03-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #212688. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.