American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10AP
Check against the official notice below — it lists the full affected range.
American Contract Systems Inc is recalling American Contract System Convenience Kits (model TNCB10AP) that were distributed nationwide in Iowa and Ohio. The kits contain Medline Red Rubber Intermittent Catheters in sizes 8Fr through 22Fr and Red Rubber Intermittent Catheter Trays. Medline Industries, LP determined that representative samples of these catheters did not meet applicable performance specifications. The recall involves 30 units with Lot Number 42-8808611, UDI 191072241252, and expiration date of January 6, 2027.
The source document does not specify a remedy or what affected consumers should do in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Quantity: 30 units Lot/code info: Lot Code: Lot Number: 42-8808611 UDI: 191072241252 Expiration Date: 1/6/2027
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.