← FDA ENFORCEMENT
Z-3001-2026Class II

American Contract Systems Inc

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
American Contract Systems Inc
Product type
Device
Status
Ongoing
Report date
2026-09-02
Distribution
US Nationwide distribution in the states of IA, OH.
Firm state
OH
Product quantity
30 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
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.

Product description

American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AN

Code / lot info

Lot Code: Lot Number: 42-8768511 UDI: 191072239907 Expiration Date: 1/6/2027

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →