FDA-Device2026-09-02Class IIPROCESSING DEFECT
American Contract Systems Convenience Kit recalled for catheter performance failure
What this means
American Contract Systems Convenience Kits (Model TNCB10AM) contain Medline Red Rubber Intermittent Catheters that do not meet performance specifications. The kits were distributed in Iowa and Ohio. No injuries have been reported.
- Check if you have this kit (Model TNCB10AM, Lot 42-8493811, Expiration 7/15/2026).
- Stop using the catheters and contact your healthcare provider for a replacement.
- Return the kit to your supplier or contact American Contract Systems for instructions.
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of IA, OH.
Affected count
30 units
Manufactured in
85 Shaffer Park Dr, N/A, Tiffin, OH, United States
Products
American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3000-2026More American Contract Systems recalls
- FDA-Device2026-09-02American Contract Systems Convenience Kits recalled for catheter performance specification failure
- FDA-Device2026-09-02American Contract Systems Convenience Kit recalled for catheters not meeting performance specifications
- FDA-Device2026-09-02American Contract Systems Convenience Kit recalled for catheter performance defect
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