FDA-Device2026-09-02Class IIPROCESSING DEFECT
American Contract Systems Convenience Kit recalled for catheter performance defect
What this means
American Contract Systems Convenience Kits containing Medline Red Rubber Intermittent Catheters did not meet required performance specifications. The affected kits were distributed in Iowa and Ohio.
- If you have this kit (Model LLPD90H, Lot 70-054952), do not use it.
- Contact your healthcare provider or American Contract Systems for instructions on obtaining a replacement or alternative catheter supply.
- Check any documentation with your kit to confirm the lot number.
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
12 units
Manufactured in
85 Shaffer Park Dr, N/A, Tiffin, OH, United States
Products
American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90H
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3003-2026Want us to check the next one for you?
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