Brand Name: Banner Health Systems Product Name: Lap Pack - 170307 Model/Catalog Number: BHLP62H Software Version: N/A Product Description: Convenience Kit Component: No
FDA Recall Z-1425-2025 · Posted 2025-03-21
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Recalling FirmAmerican Contract Systems, Inc.
Recall StatusOpen, Classified
Product CodeFDE
Date Initiated2025-01-31
Product Quantity500 kits
Reason for Recall
Sterility assurance with procedure trays
Firm Action
On 1/31/25 customers were notified via. phone about the recall. On February 11, 2025, Owens & Minor, the parent company of American Contract System issued a "Urgent: Medical Device Recall" notification via email to affected customers.
1. DISCONTINUE USE of the procedure trays listed in Table 1 above.
2. RETURN PRODUCT: Contact your ACS Sales Representative for instructions on returning all product to ACS.
3. Distributors: If any of the affected kits identified above were further distributed, please
ensure all end-users are appropriately notified of this recall and all unused product is
returned, and maintain records of effectiveness.
4. Complete the attached Recall Response Form and return as soon as possible.
Root Cause
Process change control
Distribution Pattern
US: AZ OUS: None
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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