Recall Ledger

American Contract System Convenience Kits recall (American Contract Systems Inc)

Medical deviceClass IIOngoing

Summary: American Contract Systems Inc is recalling American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10AP. Reason: 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.

What is being recalled

American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10AP

Why

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.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

US Nationwide distribution in the states of IA, OH. (states named: Iowa, Ohio)

How to tell if yours is affected

Lot Code: Lot Number: 42-8808611 UDI: 191072241252 Expiration Date: 1/6/2027

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-3002-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedJune 29, 2026
ReportedSeptember 2, 2026
CompanyAmerican Contract Systems Inc
Company locationTiffin, OH, United States
Initiated byVoluntary: Firm initiated
Quantity30 units

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Official FDA record