United StatesAmerican Contract System Convenience Kits (CV B PACK models TNCB10AM, TNCB10AN, TNCB10AP and D & C PACK model LLPD90H) bearing lot numbers 42-8493811 (UDI 191072232991, exp. 7/15/2026), 42-8768511 (UDI 191072239907, exp. 1/6/2027), 42-8808611 (UDI 191072241252, exp. 1/6/2027) and 70-054952 (UDI 191072219947) sold in IA and OH are affected. They were recalled because the kits contain Medline red rubber intermittent catheters (8Fr–22Fr) and catheter trays for which representative samples did not meet applicable performance specifications.
What's being recalled
American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM
American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AN
American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10AP
American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90H
Recalling firm: American Contract Systems Inc, Tiffin, OH, United States.
How to identify it
Lot Code: Lot Number: 42-8493811 UDI: 191072232991 Expiration Date: 7/15/2026 Lot Code: Lot Number: 42-8768511 UDI: 191072239907 Expiration Date: 1/6/2027 Lot Code: Lot Number: 42-8808611 UDI: 191072241252 Expiration Date: 1/6/2027 Lot Code: Lot Number: 70-054952 UDI: 191072219947
The 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.
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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of IA, OH.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)