American Contract System Convenience Kit — Class II medical device recall Z-3001-2026
Ongoing recall by American Contract Systems Inc, reported 2026-09-02, distributed nationwide. The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermitte
| Recall number | Z-3001-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Contract Systems Inc, Tiffin, OH, United States |
| Recall initiated | 2026-06-29 |
| Classified | 2026-08-21 |
| Reported by FDA | 2026-09-02 |
| Distributed | Nationwide (US) |
| Quantity | 30 units |
| UPC / GTIN / UDI-DI | 00191072239907 |
| Lot numbers | 42-8768511 |
| Model numbers | TNCB10AN |
| Expiration dates | 2027-01-06 |
Product
American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AN
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3001-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.