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FDA (Device enforcement)Recalled 2026-06-29class ii

American Contract Systems Inc: American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM

Is my product affected?

American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM

  • UPC 191072232991

Check against the official notice below — it lists the full affected range.

What happened

American Contract Systems Inc is recalling American Contract System Convenience Kits, Model TNCB10AM, distributed nationwide in Iowa and Ohio. The kits contain Medline Red Rubber Intermittent Catheters (sizes 8Fr-22Fr) and Red Rubber Intermittent Catheter Trays that were found not to meet applicable performance specifications. A total of 30 units are affected, specifically those with Lot Number 42-8493811 and expiration date 7/15/2026.

The recall notice does not specify a remedy or instructions for what affected consumers should do.

Written by software from the official notice below. Not reviewed by a lawyer.

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.

Details from the source

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: 42-8493811 UDI: 191072232991 Expiration Date: 7/15/2026

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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