FDA Device recall Z-0343-2025
Imed Products Imed EVA BAG, 250 mL, 2-PORTS, REF IM68045
- FDA Device
- Class II
- ongoing
- Published 2024-11-20
On 2024-11-20 the FDA classified a Class II recall of Imed Products Imed EVA BAG, 250 mL, 2-PORTS, REF IM68045 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-0343-2025 |
| 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
Imed Products Imed EVA BAG, 250 mL, 2-PORTS, REF IM68045; 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 00812496011312, Lot Numbers: 68045-A8289, 68045-A8319, 68045-A8347, 68045-A8390, 68045-A8434 |
|---|
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-0343-2025%22
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