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Open, Classified

Various Laparoscopy Packs

FDA Recall Z-1694-2022 · Posted None

Recalling FirmAmerican Contract Systems, Inc.
Recall StatusOpen, Classified
Product CodeFDE
Date Initiated2022-06-16
Product Quantity39 units

Reason for Recall

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

Firm Action

The recalling firm began notifying customers of the recall beginning June 13, 2022. Customer notification was initially made via email and an "Urgent Medical Device Recall" letter dated June 16, 2022. Customers are asked to review inventory and segregate affected product, which should be identified with the Bag Serial Number. Affected product should be destroyed, with evidence of destruction provided back to the recalling firm. A Field Action Response Form should be completed and returned to [email protected] as soon as possible, even if the customer has no inventory. If you have any questions, please call 816-920-5846.

Root Cause

Process change control

Distribution Pattern

Distribution within the United States to health systems and distributors in AZ, FL, IA, IL, MA, MN, MO, OH, NE, PA, RI, SD, and TX

Official Source

View FDA Recall →

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

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