Recall Z-3002-2026— American Contract Systems Inc

Class II · Ongoing

Class II FDA medical device recall by American Contract Systems Inc, initiated 2026-06-29. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..

Recalling firm
American Contract Systems Inc
Classification
Class II
Status
Ongoing
Initiated
2026-06-29
Firm location
Tiffin, OH, United States

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.