FDA-Device2026-09-02Class IIPROCESSING DEFECT
American Contract Systems Convenience Kit recalled for catheters not meeting performance specifications
What this means
American Contract Systems Convenience Kits contain Medline Red Rubber Intermittent Catheters that did not meet required performance specifications in testing. The affected kits were distributed in Iowa and Ohio. No injuries have been reported.
- Check if you have lot number 42-8768511 or the affected UDI 191072239907 (expiration 1/6/2027)
- Stop using the catheters from this lot and do not open new packages
- Contact your healthcare provider or Medline Industries for guidance on replacement catheters
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
All ages
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: TNCB10AN
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3001-2026More 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 catheter performance failure
- FDA-Device2026-09-02American Contract Systems Convenience Kit recalled for catheter performance defect
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