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AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays… recallZ-2465-2025 · American Contract Systems Inc · initiated Jul 14, 2025

Open, Classified

Is my device affected?

  1. 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.
  2. 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.
  3. 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

During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

FDA root cause category: Under Investigation by firm

What the company is doing

Owens & Minor issued an "URGENT: MEDICAL DEVICE CORRECTION" notice to its consignees on 07/15/2025 via email. The notice explained the problem, potential risk to health, and requested the following: ACTIONS TO TAKE: " Discontinue use of all affected components. " Add warning labels to affected procedure trays to ensure the components are discarded. A labeling template is enclosed for printing labels which can be affixed on all affected kits in inventory. This label should be applied to each affected procedure tray and product case in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. o Customers (end-users): If you receive a product from a distributor, please contact the distributor or your sales representative with any questions you may have. o Distributors: If any of the affected procedure trays identified above were further distributed, please ensure all end-users are appropriately notified of this product correction and maintain records of effectiveness for your consignees. " Complete the attached Recall Response Form and return as soon as possible to [email protected]. Report any quality problems or adverse events associated with the products listed in this notification to [email protected]. If you have any questions, contact the Manager, Regulatory Affairs at 470-280-4277 or email to: [email protected].

Recall details

Recall number
Z-2465-2025
Status
Open, Classified
Initiated by the company
Jul 14, 2025
Posted by the FDA
Aug 28, 2025
Recalling firm
American Contract Systems Inc
Quantity
1233 units
Product code
FDE
Distribution
US distribution to states of: IL and LA

Product description

AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/Item Number CILC69L; 2) LAP CHOLE PACK, Model/Item Number HNLC80J; 3) LAP CHOLE PACK, Model/Item Number JKLC55H; 4) LAPAROSCOPY PACK, Model/Item Number LLLA21K; 5) GENERAL LAPAROSCOPY MPH, Model/Item Number MPGL15G;

Code information (models, lots, serial numbers)

1) Model/Item Number CILC69L: UDI/DI 00191072235503, Kit Lot Numbers: 42-7937111, 42-8049311; 2) Model/Item Number HNLC80J: UDI/DI 00191072193650, Kit Lot Numbers: 42-8044511, 42-8118911, 42-7977011, 42-7803211; 3) Model/Item Number JKLC55H: UDI/DI 00191072235138, Kit Lot Numbers: 42-7814311; 4) Model/Item Number LLLA21K: UDI/DI 00191072233486, Kit Lot Numbers: 70-052582, 70-053048, 70-051564, 70-051373, 70-051163, 70-053446, 70-053776; 5) Model/Item Number MPGL15G: UDI/DI 00191072223197, Kit Lot Numbers: 5436916, 5436615

Devices named in this recall

5 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 97358).

Sources and updates

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