Total Knee Pack, REF CETJ130, medical convenience kits
FDA device recall Z-1973-2023 · posted 2023-06-15 · Open, Classified
Recall details
- Recalling firm
- American Contract Systems, Inc.
- Reason for recall
- Incorrect expiration date on product.
- 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.
- Root cause
- Labeling design
- Status
- Open, Classified
- Product code
- OJH
- Quantity affected
- 36 units
- Distribution
- US Distribution to the state of: MA
- Date initiated
- 2023-04-17
- Date posted
- 2023-06-15
- Location
- Kansas City, MO
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