—#212686

Product

Medline procedure kits labeled as: 1) DELIVERY PACK, Pack Number DYNJ0923016; 2) DELIVERY PACK-LF, Pack Number DYNJ0968863M; 3) L & D PACK-LF, Pack Number DYNJ0373290N; 4) L&D PACK, Pack Number DYNJ51998A; 5) LABOR & DELIVERY PACK-LF, Pack Number DYNJ0348455P; 6) LABOR AND DELIVERY TRAY-LF, Pack Number DYNJ23054J; 7) OB DELIVERY-LF, Pack Number DYNJ40096F; 8) VAG DELIVERY PACK, Pack Number DYNJ83056; 9) VAGINAL DELIVERY, Pack Number DYNJ27939D; 10) VAGINAL DELIVERY PACK, Pack Number DYNJ25843C; 11) VAGINAL DELIVERY PACK, Pack Number DYNJ43395; 12) VAGINAL DELIVERY PACK-LF, Pack Number DYNJ0594115L

FDA product code: MLS — Labor And Delivery Kit
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
Affected lot / code info: 1) Pack Number DYNJ0923016: UDI/DI 10889942099634 (each) 40889942099635 (case), Lot Number 23IMF426A; 2) Pack Number DYNJ0968863M: UDI/DI 10889942323081 (each) 40889942323082 (case), Lot Number 21JMG530A; 3) Pack Number DYNJ0373290N: UDI/DI 10193489967371 (each) 40193489967372 (case), Lot Number 21IMH700A; 4) Pack Number DYNJ51998A: UDI/DI 10193489923506 (each) 40193489923507 (case), Lot Number 22IBG256Z; 5) Pack Number DYNJ0348455P: UDI/DI 10195327430481 (each) 40195327430482 (case), Lot Number 23HMC532A; 6) Pack Number DYNJ23054J: UDI/DI 10193489215649 (each) 40193489215640 (case), Lot Number 22CMB444A; 7) Pack Number DYNJ40096F: UDI/DI 10193489923094 (each) 40193489923095 (case), Lot Number 23IMF243A; 8) Pack Number DYNJ83056: UDI/DI 10195327234416 (each) 40195327234417 (case), Lot Number 22JMB827A; 9) Pack Number DYNJ27939D: UDI/DI 10195327148232 (each) 40195327148233 (case), Lot Number 22LBE104A; 10) Pack Number DYNJ25843C: UDI/DI 10889942853731 (each) 40889942853732 (case), Lot Number 21EBN038A; 11) Pack Number DYNJ43395: UDI/DI 10888277049444 (each) 40888277049445 (case), Lot Number 21LMG173A; 12) Pack Number DYNJ0594115L: UDI/DI 10193489382730 (each) 40193489382731 (case), Lot Number 20JKB018A

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 #212686. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.