Z-2049-2016Class II

PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy

Name: Z-2049-2016 PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy
Creator: Baxter Healthcare Corp.
Published: 2016-05-23
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2016-05-23 / Terminated

FDA source

Baxter Healthcare Corp. began a recall of PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy on 2016-05-23. FDA classified it as Class II and gives the reason as "Presence of leaks near top of the PrismaSate bags". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2049-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-23
Posted: 2016-06-24
Terminated: 2017-03-28
Recalling firm: Baxter Healthcare Corporation
Product: PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy
Product code: KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Reason for recall: Presence of leaks near top of the PrismaSate bags
FDA root cause: Other
Action: Baxter Healthcare Corporation sent an Urgent Product Recall communication to affected customers via U.S.P.S. first class mail on 05/23/2016.
Quantity in commerce: 10,054 units
Distribution: Distributed to Columbia and the following US states: 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 codes and lots: 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).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2049-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2049-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-24

Product code KPO

K072908Class IIPrismasate Dialysis Solutions for Continuous Renal Replacement TherapyGambro Renal Products / cleared 2008-02-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)