FDA-Device2026-09-02Class IIPROCESSING DEFECT
American Contract Systems Convenience Kits recalled for catheter performance specification failure
What this means
American Contract Systems Convenience Kits (model TNCB10AP) containing Medline Red Rubber Intermittent Catheters were distributed with catheters that did not meet required performance specifications. The kits were distributed in Iowa and Ohio.
- Check if you have lot number 42-8808611 (expiration date 1/6/2027)
- Do not use affected catheters
- Contact your healthcare provider or American Contract Systems for instructions on replacement or disposal
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 Kits, CV B PACK, Model/Catalog Number: TNCB10AP
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3002-2026More American Contract Systems recalls
- FDA-Device2026-09-02American Contract Systems Convenience Kit recalled for catheter performance 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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