FDAFDA recall Z-3002-2026 · Sep 2, 2026
American Contract Systems Inc: American Contract System Convenience Kits recall
Recall found
Product
American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10AP
Reason for recall
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot Code: Lot Number: 42-8808611 UDI: 191072241252 Expiration Date: 1/6/2027
- Quantity
- 30 units
- Distribution
- US Nationwide distribution in the states of IA, OH.
- Recalling firm
- American Contract Systems Inc, Tiffin, OH
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-29
Source: openFDA enforcement record Z-3002-2026 · search recall number Z-3002-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.