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Open, Classified

Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029

FDA Recall Z-2520-2025 · Posted 2025-09-04

Recalling FirmO&M HALYARD INC
Recall StatusOpen, Classified
Product CodeKKX
Date Initiated2025-07-17
Product Quantity1316

Reason for Recall

Surgical drape packs may have open seals, which may compromise the sterility of the product.

Firm Action

On 7/17/2025, Field Action Customer Notifications were emailed to customers who were asked to do the following: 1) DESTROY or DISCARD the product available in your inventory per the facility's standard disposal procedure for surgical packs. 2) COMMUNICATE this Field Action to staff to ensure awareness of it. 3) If any of the affected lot identified above was further distributed, please ensure all end-users are appropriately notified of this Field Action and maintain records of effectiveness. 4) Any adverse events associated with the use of the affected product should be reported to [email protected]. 5) RETURN the completed Field Action Response Form to [email protected] as soon as possible even if you have no current product inventory. 6) If credit is requested, please get contact with the Customer Service team and send email to [email protected]. If you have any questions, please email [email protected] using the Event # FA-2025-015 in the header of the response

Root Cause

Process control

Distribution Pattern

Worldwide - US Nationwide distribution in the states of GA, AL, PA and the countries of MX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

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