FDA Device recall Z-0364-2019
EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a…
- 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 - 500 mL - Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a… by Baxter Healthcare, citing potential ability to leak once used for compounding.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0364-2019 |
| 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 - 500 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 H938738 Lot #'s: 60055343, 60080326, 60081686, 60084628, 60084630, 60091155, 60098887, and 60103959. **…Product Code H938738 Lot #'s: 60055343, 60080326, 60081686, 60084628, 60084630, 60091155, 60098887, and 60103959. **Update expansion on 02/19/2019 with lot numbers: 60066390, 60072129, 60084627, 60089799, 60104861, 60108274, 60109594, 60126011. |
|---|
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-0364-2019%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.