Z-2469-2025Class II

AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item...

Name: Z-2469-2025 AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item...
Creator: American Contract Systems Inc
Published: 2025-07-14
License: https://open.fda.gov/license/

American Contract Systems, Inc. / initiated 2025-07-14 / Open, Classified / root cause: sterility

FDA source

American Contract Systems Inc began a recall of AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLBN11C; 2) LABOR & DELIVERY PACK, Model/Item... on 2025-07-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2469-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-14
Posted: 2025-08-28
Recalling firm: American Contract Systems, Inc.
Product: AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLBN11C; 2) LABOR & DELIVERY PACK, Model/Item Number LLLD19I.
Product code: MLS Labor And Delivery Kit
Reason for recall: 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.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: 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].
Quantity in commerce: 781 units
Distribution: US distribution to states of: IL and LA
Product codes and lots: 1) Model/Item Number LLBN11C: UDI/DI 00191072233530, Kit Lot Numbers: 70-051710, 70-052354; 2) Model/Item Number LLLD19I: UDI/DI 00191072233493, Kit Lot Numbers: 70-051324, 70-051967, 70-053006, 70-053303, 70-053710.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2469-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2464-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-03	2025-08-28
Z-2465-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-03	2025-08-28
Z-2466-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-03	2025-08-28
Z-2467-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-03	2025-08-28
Z-2468-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-03	2025-08-28
Z-2469-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-03	2025-08-28
Z-2470-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-03	2025-08-28
Z-2471-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-03	2025-08-28
Z-2472-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-03	2025-08-28

Product code MLS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)