—#208747

Product

Medline Convenience kits labeled as: SCS-LF, DYNJ902314D

FDA product code: LRW — Scissors, General, Surgical
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: DYNJ902314D, Lot Number 20FDA446 ; DYNJ902314D, Lot Number 20GDA480 ; DYNJ902314D, Lot Number 20IDA880 ; DYNJ902314D, Lot Number 20JDA187 ; DYNJ902314D, Lot Number 21CDA064 ; DYNJ902314D, Lot Number 21EDA709 ; DYNJ902314D, Lot Number 21EDA908 ; DYNJ902314D, Lot Number 21FDA451 ; DYNJ902314D, Lot Number 21FDB959 ; DYNJ902314D, Lot Number 21HDA759 ; DYNJ902314D, Lot Number 21IDC401 ; DYNJ902314D, Lot Number 21KDC395 ; DYNJ902314D, Lot Number 22CDA599 ; DYNJ902314D, Lot Number 22EDB585 ; DYNJ902314D, Lot Number 22IDA541 ; DYNJ902314D, Lot Number 22KDB745 ; DYNJ902314D, Lot Number 23BDA383 ; DYNJ902314D, Lot Number 23DDB444 ; DYNJ902314D, Lot Number 23EDA371

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 04/08/2024 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 these 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. The firm issued a second recall notice (an expansion) on 05/02/2024 using the same methods.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution.

Timeline

Recall initiated: 2024-04-08
Posted by FDA: 2024-09-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #208747. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.