FDA Device recall Z-0363-2019
EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a pa…
- 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 - 250 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a pa… by Baxter Healthcare, citing potential ability to leak once used for compounding.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0363-2019 |
| 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 - 250 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 H938737 Lot #'s: 60064550, 60070834, 60075460, 60083515, 60088184, 60089783, 60091143, 60097820, 60098862…Product Code H938737 Lot #'s: 60064550, 60070834, 60075460, 60083515, 60088184, 60089783, 60091143, 60097820, 60098862 and 60106876. **Update expansion on 02/19/2019 with additional lot numbers: 60092411, 60093840, 60096703, 60103940, 60110724, 60112088, 60116852, 60119378, 60119379, 60127187, 60128808. |
|---|
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-0363-2019%22
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