FDA-Device2016-07-06Class II
PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy
Baxter Healthcare Corp.
Hazard
Presence of leaks near top of the PrismaSate bags
Sold states
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
Affected count
10,054 units
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2049-2016Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief