FDA Device recall Z-0366-2019
EXACTAMIX Empty EVA Bags - 2000 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 - 2000 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-0366-2019 |
| 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 - 2000 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 H938740 Lot #'s: 60049816, 60049819, 60051309, 60051792, 60051793, 60051794, 60053089, 60053090, 60053843,…Product Code H938740 Lot #'s: 60049816, 60049819, 60051309, 60051792, 60051793, 60051794, 60053089, 60053090, 60053843, 60059169, 60061937, 60063161, 60066271, 60066272, 60068167, 60068168, 60069705, 60070832, 60073335, 60074714, 60078334, 60078390, 60078970, 60080309, 60081656, 60081677, 60081679, 60086988, 60091144, 60098870, 60101111, 60105444, 60108266, and 60108272. **Update expansion on 02/19/2019 additional lot numbers: 60059167, 60063151, 60064579, 60066278, 60068169, 60069693, 60072140, 60080308, 60083768, 60088207, 60088208, 60095450, 60096708, 60101121, 60105434, 60105447, 60106883, 60106884, 60108267, 60108268, 60108271, 60109577, 60110736, 60110738, 60115246, 60115250, 60118324, 60119397, 60119787, 60119788, 60119790, 60120960, 60120965, 60124664, 60126015, 60126020, 60127214, 60128818. |
|---|
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-0366-2019%22
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