—#188258

Product

Medline Arthroscopy Kit, convenience kit, REF DYNJ904304B, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).

FDA product code: OJH — Orthopedic Tray
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot 19IBR389, Exp. 2020-09-30, GTIN (01)10889942833290.

Why it was recalled

The kits may contain an expired component.

Root cause (FDA determination)

Employee error

Action the firm took

Consignees were notified by letter dated and issued on 7/1/2021 via first class mail. The letter informed the consignee the convenience kits were being recalled due to the irrigation bag expiring August 21,2020. The consignee was to immediately check their stock for the affected kit and kit lot number and affix the enclosed sticker on the kit which instructs the consignee to remove the expired irrigation bag and replace it with sterile product from their supply. The remainder of the components may be used.

Recalling firm

Firm: Medline Industries Inc
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: US Nationwide distribution in the states of MN, NE, and PA.

Timeline

Recall initiated: 2021-07-01
Terminated: 2023-03-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #188258. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.