Recall Z-3000-2026— 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 Kit, CV B PACK, Model/Catalog Number: TNCB10AM. 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 Kit, CV B PACK, Model/Catalog Number: TNCB10AM
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.