American Contract Systems Inc: Cardiovascular Procedure Kit
Recall Summary American Contract Systems Inc is recalling Convenience Kits (Model TNCB10AN) used in cardiovascular procedures because they contain Red Rubber Intermittent Catheters that failed to meet performance specifications. The kits were distributed nationwide, though the primary distribution was in Iowa and Ohio. This is a Class II recall affecting medical devices.
- Recalling firm
- American Contract Systems Inc
- Product
- American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AN
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-29
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of IA, OH.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/6596f4d6-418c-469c-8fe3-fdd99b4aa089