—#212693

Product

Medline procedure kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Number 613034700, 2) C SCOPE DISPOSABLE KIT, Pack Number 613034702

FDA product code: HRX — Arthroscope
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K203526
Affected lot / code info: 1) Pack Number 613034700: UDI/DI 10850009724004 (each) 40850009724005 (case), Lot Number 613034700; 2) Pack Number 613034702: UDI/DI 10850009724066 (each) 40850009724067 (case), Lot Number 613034702

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 #212693. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.