American Contract Systems Inc: Cardiovascular Procedure Kit
Recall Summary American Contract Systems Inc is recalling Cardiovascular Procedure Kits (Convenience Kits and D & C Packs, Model LLPD90H) that contain Medline red rubber catheters because sample testing found the catheters did not meet required performance specifications. These kits were distributed nationwide. This is a Class II recall, meaning use of the product could result in serious injury or illness.
- Recalling firm
- American Contract Systems Inc
- Product
- American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90H
- 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/36bff03f-b0a6-4dab-a639-87b046554283