Recall Z-1973-2023
American Contract Systems, Inc. · initiated April 17, 2023
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Total Knee Pack, REF CETJ130, medical convenience kits
Codes / lots: UDI/DI: 00191072179593; Lot Number: 967231
Reason for recall
Incorrect expiration date on product.
FDA-determined 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.
Details
- Recall number
- Z-1973-2023
- Initiated
- April 17, 2023
- Posted by FDA
- June 15, 2023
- Product code
- OJH – Orthopedic Tray
- Quantity
- 36 units
- Distribution
- US Distribution to the state of: MA
- Recalling firm
- American Contract Systems, Inc., Kansas City, MO