Total Knee Pack, REF CETJ130, medical convenience kits
- Company
- American Contract Systems, Inc.
- Recall Initiated
- April 17, 2023
- Posted
- June 15, 2023
- Recall Number
- Z-1973-2023
- Quantity
- 36 units
- Firm Location
- Kansas City, MO
Reason for Recall
Incorrect expiration date on product.
Distribution
US Distribution to the state of: MA
Lot / Code Info
UDI/DI: 00191072179593; Lot Number: 967231
Root Cause
Labeling design
Action Taken
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.