American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90H
Check against the official notice below — it lists the full affected range.
American Contract Systems Inc is recalling its American Contract System Convenience Kit, Model LLPD90H, because the kits contain Medline Red Rubber Intermittent Catheters (sizes 8Fr-22Fr) and Red Rubber Intermittent Catheter Trays that did not meet applicable performance specifications in testing. The affected products were distributed nationwide in Iowa and Ohio, with 12 units involved in this recall. The affected lot number is 70-054952.
The record does not specify what consumers should do regarding 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: 12 units Lot/code info: Lot Code: Lot Number: 70-054952 UDI: 191072219947
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.