ExactaMix — Class II medical device recall Z-0007-2020
Ongoing recall by The Metrix Company, reported 2019-10-09, distributed nationwide. Potential for leaking product
| Recall number | Z-0007-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Metrix Company, Dubuque, IA, United States |
| Recall initiated | 2018-09-21 |
| Classified | 2019-10-01 |
| Reported by FDA | 2019-10-09 |
| Distributed | Nationwide (US) |
| Quantity | 175,392 bags |
| Reason classes | packaging |
| Lot numbers | 63615, 63615-A1768, 63615-A1770, 63615-A1772, 63615-A2648, 63615-A2650, 63615-A2652, 63615-A2653, 63615-A2654, 63615-A2656, 63615-A2658, 63615-A2660, 63615-A2662, 63615-A3951, 63615-A3955, 63615-A3958, 63615-A3960, 63615-A3962, 63615-A3964, 63615-A3966, 63615-A3967, 63615-A5337, 63615-A5339, 63615-A5341, 63615-A5343, 63615-A5345, 63615-A5347, 63615-A5349, A3953, H938901 |
| Model numbers | H938901 |
Product
ExactaMix, Model: H938901, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 500 ml/ 2500 ml, Baxter - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Reason for recall
Potential for leaking product
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-0007-2020. 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.