Baxter EXACTAMIX Inlet — Class II medical device recall Z-1908-2018
Terminated recall by Baxter Healthcare Corporation, reported 2018-05-30. Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were ove
| Recall number | Z-1908-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2018-04-25 |
| Classified | 2018-05-22 |
| Reported by FDA | 2018-05-30 |
| Terminated | 2020-12-16 |
| Quantity | 98,700 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00085412475783 |
| Lot numbers | 802277, 802278, 802383, 802384, 802385 |
| Model numbers | H938173 |
Product
Baxter EXACTAMIX Inlet, Non-Vented, High-Volume Inlet, REF H938173 Product 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 for recall
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,
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1908-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.