FDA Device recall Z-3000-2026
American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM
- FDA Device
- Class II
- ongoing
- Published 2026-09-02
On 2026-09-02 the FDA classified a Class II recall of American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM by American Contract Systems, citing the Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representati….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3000-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-29 |
| Published | 2026-09-02 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | American Contract Systems |
| Distribution | US |
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.
Identifiers
| code_info | Lot Code: Lot Number: 42-8493811 UDI: 191072232991 Expiration Date: 7/15/2026 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3000-2026%22
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