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U.S. Department of Health and Human Services

Class 2 Device Recall Medline Knee Arthroscopy Kit

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  Class 2 Device Recall Medline Knee Arthroscopy Kit see related information
Date Initiated by Firm July 01, 2021
Create Date August 09, 2021
Recall Status1 Terminated 3 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/
Medline Industries Inc
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information Contact Ms. Kassandra Cotner
Manufacturer Reason
for Recall
The kits may contain an expired component.
FDA Determined
Cause 2
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.