FDA Device recall Z-1910-2018
Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposabl…
- FDA Device
- Class II
- terminated
- Published 2018-05-30
On 2018-05-30 the FDA classified a Class II recall of Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposabl… by Baxter Healthcare, citing specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1910-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-25 |
| Published | 2018-05-30 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Baxter Healthcare |
| Distribution | n/a |
Product
Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.
Reason
Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the expiration date,
Identifiers
| code_info | UDI: 00085412475806 Lot Numbers: 802282, 802283 |
|---|
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-1910-2018%22
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