American Contract Systems Inc recalls American Contract System Convenience Kit

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.

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.

• FDA enforcement recordOfficial FDA database entry for Z-3003-2026
• FDA device classification · OEZOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.1200The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find American Contract Systems IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.