FDA Device recall Z-2049-2016
PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy
- FDA Device
- Class II
- terminated
- Published 2016-07-06
On 2016-07-06 the FDA classified a Class II recall of PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy by Baxter Healthcare, citing presence of leaks near top of the PrismaSate bags.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2049-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-23 |
| Published | 2016-07-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Baxter Healthcare |
| Distribution | 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 |
Product
PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy
Reason
Presence of leaks near top of the PrismaSate bags
Identifiers
| code_info | Listing #D051124, Unique Device Identifier #07332414037048, Product code #105351. Lot code (Exp date): 1000123133 (02/2…Listing #D051124, Unique Device Identifier #07332414037048, Product code #105351. Lot code (Exp date): 1000123133 (02/28/2017), 1000128162 (04/30/2017), 1000128163 (04/30/2017), 1000128164 (04/30/2017). |
|---|
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-2049-2016%22
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