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U.S. Department of Health and Human Services

Class 2 Device Recall Medline

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  Class 2 Device Recall Medline see related information
Date Initiated by Firm July 03, 2023
Date Posted August 10, 2023
Recall Status1 Open3, Classified
Recall Number Z-2366-2023
Recall Event ID 92736
Product Classification Orthopedic tray - Product Code OJH
Product Total Hip Kit, REF DYNJ903275S; surgical convenience kit
Code Information UDI/DI: 10195327254582 (unit), 40195327254583 (case); Lot code 23CDC733
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information Contact Karin Johnson
226-359-1704
Manufacturer Reason
for Recall		 The prep solution included in the Total Hip Kit expires prior to the expiration date of the Kit.
FDA Determined
Cause 2		 Under Investigation by firm
Action Medline notified its sole consignee by email on 07/07/2023, The consignee was instructed to destroy any affected product that they may have on hand.
Quantity in Commerce 16 kits
Distribution US Nationwide distribution in the state of Illinois.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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