FDA Device recall Z-0336-2025
SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed), REF 66041
- FDA Device
- Class II
- ongoing
- Published 2024-11-20
On 2024-11-20 the FDA classified a Class II recall of SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed), REF 66041 by The Metrix, citing A limited number of IV bags have been found to leak during filling.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0336-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-09 |
| Published | 2024-11-20 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | The Metrix |
| Distribution | US |
Product
SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed), REF 66041; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Reason
A limited number of IV bags have been found to leak during filling.
Identifiers
| code_info | UDI/DI 50812496011553, Lot Numbers: 66041-A8296, 66041-A8343, 66041-A8386, 66041-A8418, 66041-A8433 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0336-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.