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U.S. Department of Health and Human Services

Class 2 Device Recall AMERICAN CONTRACT SYSTEMS

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 Class 2 Device Recall AMERICAN CONTRACT SYSTEMSsee related information
Date Initiated by FirmJuly 14, 2025
Date PostedAugust 28, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2466-2025
Recall Event ID 97358
Product Classification Endoscope introducer kit - Product Code NWU
ProductAMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) CYSTO, Model/Item Number ASCY24A; 2) CYSTO PACK, Model/Item Number BUCY78E; 3) CYSTO PACK, Model/Item Number LMCP22T; 4) TUR BASIN PACK, Model/Item Number LMTU31T; 5) CYSTO, Model/Item Number SACY80S; 6) UROLOGY PACK, Model/Item Number SPUR64F.
Code Information 1) Model/Item Number ASCY24A: UDI/DI 00191072201621, Kit Lot Numbers: 12-7370111, 12-7388611, 12-7388611, 12-7139611, 12-7191911, 12-7231611, 12-7263911; 2) Model/Item Number BUCY78E: UDI/DI 00191072235350, Kit Lot Numbers: 42-7962811; 3) Model/Item Number LMCP22T: UDI/DI 00191072235510, Kit Lot Numbers: 42-8027411, 42-8106111, 42-7885511, 42-7823511; 4) Model/Item Number LMTU31T: UDI/DI 00191072235527, Kit Lot Numbers: 42-7987311, 42-8059311, 42-8112211, 42-7832311, 42-7845011, 42-7914911; 5) Model/Item Number SACY80S: UDI/DI 00191072233370, Kit Lot Numbers: 70-052954, 70-052248, 70-51139, 70-053309, 70-053805; 6) Model/Item Number SPUR64F: UDI/DI 00191072238764, Kit Lot Numbers: 12-7394711, 12-7328411, 12-7096811, 12-7168211.
FEI Number 3008492337
Recalling Firm/
Manufacturer		 American Contract Systems Inc
85 Shaffer Park Dr
Tiffin OH 44883-9290
For Additional Information ContactMarlene Jones
470-280-4277
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionOwens & 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 GM-OMRA_RECALLS@owens-minor.com. Report any quality problems or adverse events associated with the products listed in this notification to complaints@owens-minor.com. If you have any questions, contact the Manager, Regulatory Affairs at 470-280-4277 or email to: GM-OMRA_RECALLS@owens-minor.com.
Quantity in Commerce1127 units
DistributionUS distribution to states of: IL and LA
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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