Class 2 Device Recall American Contract System, ACS

• Date Initiated by Firm: June 29, 2026
• Date Posted: August 21, 2026
• Recall Status: Open, Classified
• Recall Number: Z-3002-2026
• Recall Event ID: 99514
• Product Classification: Cardiovascular procedure kit - Product Code OEZ
• Product: American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10AP
• Code Information: Lot Code: Lot Number: 42-8808611 UDI: 191072241252 Expiration Date: 1/6/2027
• FEI Number: 3008492337
• Recalling Firm/ Manufacturer: American Contract Systems Inc; 85 Shaffer Park Dr; Tiffin OH 44883-9290
• For Additional Information Contact: Marlene Jones; +1-470-2804277
• Manufacturer Reason for Recall: The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.
• FDA Determined Cause: Nonconforming Material/Component
• Action: An URGENT: MEDICAL DEVICE RECALL NOTIFICATION letter dated 6/29/26 was sent to customers. ACTIONS TO TAKE: "Identify, segregate, and quarantine all impacted product. Other components within the convenience kits can still be used once kit is properly labeled with the warning label below. "Add warning labels to affected ACS kits to ensure all users are aware of the actions below and identified in the enclosed Medline recall notice. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. Please contact your Sales Representative if pre-printed labels are needed. This label should be applied in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. "Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have, or to request printed labels. "Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. "Complete the attached Recall Response Form and return by July 17, 2026. Report any quality problems or adverse events associated with the products listed in this notification to complaints@owens-minor.com . Your assistance is appreciated and necessary to prevent any risk to patient or medical professional health as a result of not following these instructions.
• Quantity in Commerce: 30 units
• Distribution: US Nationwide distribution in the states of IA, OH.
• Total Product Life Cycle: TPLC 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.