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Open, Classified

Total Knee Pack, REF CETJ130, medical convenience kits

FDA Recall Z-1973-2023 · Posted 2023-06-15

Recalling FirmAmerican Contract Systems, Inc.
Recall StatusOpen, Classified
Product CodeOJH
Date Initiated2023-04-17
Product Quantity36 units

Reason for Recall

Incorrect expiration date on product.

Firm 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 [email protected]. If you have any questions, contact Regulatory Affairs Manager, Global Products at 470-280-4277 or email: [email protected].

Root Cause

Labeling design

Distribution Pattern

US Distribution to the state of: MA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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