—#212668

Product

Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ909098

FDA product code: OHM — Cesarean Section Tray
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
Affected lot / code info: 1) 10195327273132 (each) 40195327273133 (case), Lot Number 23GBK039Z

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 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 94581

Recalling firm

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

Distribution

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

Timeline

Recall initiated: 2025-02-11
Posted by FDA: 2025-03-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #212668. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.