Medical device recalls Moderate risk

Baxter Healthcare Corp. recalls PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy

Recall date
May 23, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2049-2016
FDA classification
Class II
Brand / firm
Baxter Healthcare Corp.
Sold / distributed
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

Why it was recalled

Presence of leaks near top of the PrismaSate bags

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy

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