American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AN
Check against the official notice below — it lists the full affected range.
American Contract Systems Inc is recalling American Contract System Convenience Kits (Model TNCB10AN) that contain Medline Red Rubber Intermittent Catheters in sizes 8Fr through 22Fr and related catheter trays. Medline Industries, LP determined that representative samples of these catheters did not meet applicable performance specifications. The affected product was distributed nationwide in Iowa and Ohio, with 30 units involved in the recall. The affected lot has Lot Number 42-8768511, UDI 191072239907, and an expiration date of January 6, 2027.
The source document does not specify what consumers should do regarding this recall or what remedy is available.
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: 42-8768511 UDI: 191072239907 Expiration Date: 1/6/2027
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.