Class 2 Device Recall Medline Knee Arthroscopy Kit

• Date Initiated by Firm: July 01, 2021
• Create Date: August 09, 2021
• Recall Status: Terminated on March 02, 2023
• Recall Number: Z-2232-2021
• Recall Event ID: 88268
• Product Classification: Orthopedic tray - Product Code OJH
• Product: Medline Knee Arthroscopy Kit, convenience kit, REF DYNJ902838C, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
• Code Information: Lot 19WBA897, Exp. 2020-12-31, GTIN (01)10193489225143.
• Recalling Firm/ Manufacturer: Medline Industries Inc; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Ms. Kassandra Cotner; 866-359-1704
• Manufacturer Reason for Recall: The kits may contain an expired component.
• FDA Determined Cause: Employee error
• Action: 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.
• Quantity in Commerce: 286 kits total for all products
• Distribution: US Nationwide distribution in the states of MN, NE, and PA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.