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Terminated

Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.

FDA Recall Z-1449-2022 · Posted None

Recalling FirmAesculap Implant Systems LLC
Recall StatusTerminated
Product CodePUI
Date Initiated2019-10-01
Date Terminated2024-06-06
Product Quantity4500 pieces

Reason for Recall

Packaging seal integrity not validated resulting in a lack of sterility assurance.

Firm Action

Recall notice issued October 1, 2019 via letter mailed USPS certified mail with return receipt. Customers are to review inventory, return affected product and the acknowledgement form. For questions contact (800) 282-9000 or email: [email protected]

Root Cause

Package design/selection

Distribution Pattern

United States: CA, CO, GA, IL, IN, KY, MI, NC, NE, NY, OH, RI, VA and WI

Official Source

View FDA Recall →

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

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