American Contract Systems Inc: Cardiovascular Procedure Kit
Recall Summary American Contract Systems Inc is recalling Convenience Kits for cardiovascular procedures that contain red rubber intermittent catheters because some samples failed to meet required performance standards. The kits were distributed nationwide. This is a Class II recall, meaning the product could cause serious adverse health consequences but is not expected to cause death.
- Recalling firm
- American Contract Systems Inc
- Product
- American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM
- 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/34eae0f1-bd1e-4e81-a409-cce188d93d62