Official recall notice
FDA DeviceClass IINotable
FDA Recall: American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AN
- Recall date
- 2026-09-02
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
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.
Product description
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.
Affected products
Lot Code: Lot Number: 42-8768511 UDI: 191072239907 Expiration Date: 1/6/2027