PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy
FDA Recall Z-2049-2016 · Posted 2016-06-24
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Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeKPO
Date Initiated2016-05-23
Date Terminated2017-03-28
Product Quantity10,054 units
Reason for Recall
Presence of leaks near top of the PrismaSate bags
Firm 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.
Root Cause
Other
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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