—#212680

Product

Medline procedure kits labeled as: 1) CT BIOPSY PACK, Pack Number DYNJ62734A; 2) E R C P PACK, Pack Number DYNJ44115A; 3) LARGE BIOPSY PACK NTX, Pack Number DYNJ68393A

FDA product code: OFG — Ct Biopsy Tray
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: 1) Pack Number DYNJ62734A: UDI/DI 10193489242225 (each) 40193489242226 (case), Lot Number 21IME904A; 2) Pack Number DYNJ44115A: UDI/DI 10889942308187 (each) 40889942308188 (case), Lot Number 21EMF484A; 3) Pack Number DYNJ68393A: UDI/DI 10193489939996 (each) 40193489939997 (case), Lot Number 22KBW583A

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 #212680. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.