FDA recall Z-3003-2026

American Contract Systems Inc · Class II · device

Product

American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90H

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.

Distribution

US Nationwide distribution in the states of IA, OH.

Key facts

Status: Ongoing
Initiation date: 2026-06-29
Report date: 2026-09-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Tiffin, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3003-2026