Baxter Healthcare Corp.: Medical Device Recall in 2016 - (Recall #: Z-2049-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy

Product Classification:

Class II

Date Initiated: May 23, 2016

Date Posted: July 6, 2016

Recall Number: Z-2049-2016

Event ID: 74226

Reason for Recall:

Presence of leaks near top of the PrismaSate bags

Status: Terminated

Product Quantity: 10,054 units

Code Information:

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).

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated