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Open, Classified

1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack

FDA Recall Z-1037-2022 · Posted None

Recalling FirmAmerican Contract Systems, Inc.
Recall StatusOpen, Classified
Product CodeOJH
Date Initiated2022-03-22
Product Quantity114 packs

Reason for Recall

Product was sterilized with a higher than specification EO concentration.

Firm Action

A customer letter dated 04/05/2022 was issued to impacted consignees. The letter instructs the following: 1) Review your inventory and segregate affected product. This product should not be shipped out to customers. 2) Return affected product to 2610 NE Industrial Drive, Suite 220, Kansas City, MO 64120. 3) If product was already further distributed, ensure that all downstream customers are properly notified of the recall and maintain records of effectiveness. A Field Action Response Form should be completed and returned to [email protected], even if you do not have product inventory.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution in the states of IL, MO, NE, and TX.

Official Source

View FDA Recall →

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

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