FDA Device recall Z-0367-2019
EXACTAMIX Empty EVA Bags - 3000 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 - 3000 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-0367-2019 |
| 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 - 3000 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 H938741 Lot #'s: 60056339, 60066281, 60066284, 60066289, 60073320, 60099757, and 60103967. **Update e…Product Code H938741 Lot #'s: 60056339, 60066281, 60066284, 60066289, 60073320, 60099757, and 60103967. **Update expansion on 02/19/2019 additional lot numbers: 60055892, 60064600, 60078408, 60091166, 60094120, 60094126, 60099759, 60101131, 60101132, 60101135, 60101136, 60102485, 60103966, 60105206, 60105404, 60106918, 60117111, 60117113, 60117116, 60120934, 60120936, 60120938, 60120939, 60122729, 60122730, 60122731, 60128813, 60128814, 60128815, 60131891, 60132230, 60132231. |
|---|
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-0367-2019%22
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