EXACTAMIX Empty EVA — Class II medical device recall Z-0167-2020
Terminated recall by Baxter Healthcare Corporation, reported 2019-10-30, distributed nationwide. Potential ability to leak once used for compounding.
| Recall number | Z-0167-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2019-09-18 |
| Classified | 2019-10-21 |
| Reported by FDA | 2019-10-30 |
| Terminated | 2021-02-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BM, BR, CA, CL, DO, HK, KR, MX, NZ, PA, SG, TH, TW, UY |
| Quantity | 11,389,800 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00085412477213, 00085412477220, 00085412477237, 00085412477244, 00085412477251 |
| Lot numbers | 60049703, 60049820, 60051310, 60052592, 60052693, 60053851, 60053854, 60053855, 60055340, 60055342, 60056225, 60056226, 60056227, 60056338, 60056340, 60056343, 60057619, 60057621, 60057622, 60057623, 60057624, 60057625, 60057626, 60057627, 60059168, 60059170, 60059171, 60059176, 60059214, 60059219, 60059220, 60059229, 60059230, 60059241, 60059242, 60060402, 60060423, 60060424, 60060425, 60060435 and 460 more |
| Expiration dates | 2020-02-29, 2020-03-31, 2020-04-30 |
Product
EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following product code and sizes: 1. H938737, 250mL; 2. H938738, 500mL; 3. H938739, 1000mL; 4. H938740, 2000mL; 5. H938741, 3000mL Product Usage: The EXACTAMIX Empty EVA bags are used as the destination container in compounding of large-volume sterile solutions for further administration to a single patient. The empty bags are used at pharmacies and compounding centers by pharmacists and pharmacy technicians to compound multi-ingredient solutions, as prescribed by a physician.
Reason for recall
Potential ability to leak once used for compounding.
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-0167-2020. 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.