SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports — Class II medical device recall Z-0335-2025
Ongoing recall by The Metrix Company, reported 2024-11-20, distributed nationwide. A limited number of IV bags have been found to leak during filling.
| Recall number | Z-0335-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Metrix Company, Dubuque, IA, United States |
| Recall initiated | 2024-10-09 |
| Classified | 2024-11-08 |
| Reported by FDA | 2024-11-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00812496011541 |
| Lot numbers | 66040-A8314, 66040-A8368, 66040-A8417, 66040-A8482 |
| Model numbers | 66040 |
Product
SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports, REF 66040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Reason for recall
A limited number of IV bags have been found to leak during filling.
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-0335-2025. 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.