Recall Z-3001-2026 ยท OEZ Cardiovascular Procedure Kit
American Contract Systems Inc
American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AN
| Date | Aug 21, 2026 (initiated Jun 29, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root 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 |
| Quantity | 30 units |
| Distribution | US Nationwide distribution in the states of IA, OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.