Brand Name: Banner Health Systems Product Name: Lap Pack - 170307 Model/Catalog Number: BHLP62H Software Version: N/A Product Description: Convenience Kit Component: No
Recall
- Recall Number
- Z-1425-2025
- Event Number
- 96321
- Firm
- American Contract Systems, Inc.
- FEI Number
- 3010126341
- Product Code
- FDE
- Status
- Open, Classified
- Root Cause
- Process change control
- Initiated
- January 31, 2025
- Posted
- March 21, 2025
- Address
- 7300 W Detroit St, Chandler, AZ, 85226-2410
Description
Brand Name: Banner Health Systems Product Name: Lap Pack - 170307 Model/Catalog Number: BHLP62H Software Version: N/A Product Description: Convenience Kit Component: No
Sterility assurance with procedure trays
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.
US: AZ OUS: None
500 kits