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Recall Observatory FDA recall evidence

Device product

PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy

Z-2049-2016

May 23, 2016

Class II

Product summary

Firm
Baxter Healthcare Corp.
Event
Event 74226
Status
Terminated
Classification
Class II
Quantity
10,054 units
Official record key
device-enforcement:Z-2049-2016

Official wording

Reason: Presence of leaks near top of the PrismaSate bags

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Presence of leaks near top of the PrismaSate bags