American Contract Systems Inc: Cardiovascular Procedure Kit
Recall Summary American Contract Systems Inc is recalling Cardiovascular Procedure Kits (CV B PACK, Model TNCB10AP) that contain Red Rubber Intermittent Catheters because sample units failed to meet performance specifications. The kits were distributed nationwide, with primary distribution in Iowa and Ohio. This is a Class II recall affecting medical devices.
- Recalling firm
- American Contract Systems Inc
- Product
- American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10AP
- 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/b96ab3fb-9a44-4bcc-a53b-c41b5e1be7a2