Brand Name: Banner Health Systems Product Name: Lap Pack - 170307 Model/Catalog Number: BHLP62H Software Version: N/A Product Description: Convenience Kit Component: No
This recall is currently active, issued March 21, 2025. It was issued by American Contract Systems, Inc..
- Company
- American Contract Systems, Inc.
- Recall Initiated
- January 31, 2025
- Posted
- March 21, 2025
- Recall Number
- Z-1425-2025
- Quantity
- 500 kits
- Firm Location
- Chandler, AZ
- Official Source
- View on FDA website ↗
Reason for Recall
Sterility assurance with procedure trays
Distribution
US: AZ OUS: None
Lot / Code Info
Lot Code: UDI-DI: 00191072233776; Lot: 9219420; Exp: 01/21/2026
Root Cause
Process change control
Action Taken
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.