Brand Name: Banner Health Systems recallZ-1425-2025 · American Contract Systems, Inc. · initiated Jan 31, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from American Contract Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Sterility assurance with procedure trays
FDA root cause category: Process change control
What the company is doing
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.
Recall details
- Recall number
- Z-1425-2025
- Status
- Open, Classified
- Initiated by the company
- Jan 31, 2025
- Posted by the FDA
- Mar 21, 2025
- Recalling firm
- American Contract Systems, Inc.
- Quantity
- 500 kits
- Product code
- FDE
- Distribution
- US: AZ OUS: None
Product 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
Code information (models, lots, serial numbers)
Lot Code: UDI-DI: 00191072233776; Lot: 9219420; Exp: 01/21/2026
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ACS BHLP62HAmerican Contract Systems, Inc. · laparoscopy kit1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 96321).
- Z-1424-2025 · Open, ClassifiedBrand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Convenience Kit Component: No
- Z-1426-2025 · Open, ClassifiedBrand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack-170278 Model/Catalog Number: GSCC40G Software Version: N/A Product Description: Convenience Kit Compone…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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