FDA Device recall Z-0365-2019
EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a p…
- FDA Device
- Class II
- terminated
- Published 2018-11-07
On 2018-11-07 the FDA classified a Class II recall of EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a p… by Baxter Healthcare, citing potential ability to leak once used for compounding.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0365-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-09-12 |
| Published | 2018-11-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
Reason
Potential ability to leak once used for compounding.
Identifiers
| code_info | Product Code H938739 Lot #'s: 60066021, 60069101, 60072119, 60075857, 60080377, 60084632, and 60095474. **Update exp…Product Code H938739 Lot #'s: 60066021, 60069101, 60072119, 60075857, 60080377, 60084632, and 60095474. **Update expansion on 02/19/2019 with additional lot numbers: 60070846, 60081688, 60097844, 60098902, 60110761, 60110765, 60120570, 60124005, 60124006, 60124008, 60126009. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0365-2019%22
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