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U.S. Department of Health and Human Services

Class 3 Device Recall AMERICAN CONTRACT SYSTEMS medical convenience kits

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  Class 3 Device Recall AMERICAN CONTRACT SYSTEMS medical convenience kits see related information
Date Initiated by Firm April 17, 2023
Date Posted June 15, 2023
Recall Status1 Open3, Classified
Recall Number Z-1973-2023
Recall Event ID 92240
Product Classification Orthopedic tray - Product Code OJH
Product Total Knee Pack, REF CETJ130, medical convenience kits
Code Information UDI/DI: 00191072179593; Lot Number: 967231
Recalling Firm/
Manufacturer		 American Contract Systems, Inc.
2610 Ne Industrial Dr Ste 220
Kansas City MO 64117-2648
For Additional Information Contact Marlene Jones
470-280-4277
Manufacturer Reason
for Recall		 Incorrect expiration date on product.
FDA Determined
Cause 2		 Labeling design
Action Owens & Minor sent an "URGENT Product Field Correction" notice on 04/17/2023 to its sole consignee by email. The notice explained the issue and requested the following actions be taken: Identify and segregate and quarantine the affected kits in inventory. Notify all end users of this action and add labels containing correct expiration to kits. The affected product is to be relabeled using the labeling template provided. Report any quality problems or adverse events associated with the products listed in this notification to PIQ@owens-minor.com. If you have any questions, contact Regulatory Affairs Manager, Global Products at 470-280-4277 or email: GM-OMRA_RECALLS@owens-minor.com.
Quantity in Commerce 36 units
Distribution US Distribution to the state of: MA
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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