PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement… — Class II medical device recall Z-2049-2016
Terminated recall by Baxter Healthcare Corp., reported 2016-07-06, distributed in AZ, CA, CO, DE, FL, GA, IA, ID…. Presence of leaks near top of the PrismaSate bags
| Recall number | Z-2049-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Deerfield, IL, United States |
| Recall initiated | 2016-05-23 |
| Classified | 2016-06-24 |
| Reported by FDA | 2016-07-06 |
| Terminated | 2017-03-28 |
| Distributed | AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OR, PA, TN, TX, UT, VA, WA, WI |
| Quantity | 10,054 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 07332414037048 |
| Lot numbers | 1000123133, 1000128162, 1000128163, 1000128164 |
Product
PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy
Reason for recall
Presence of leaks near top of the PrismaSate bags
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-2049-2016. 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.