PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy
This recall has been terminated (originally issued June 24, 2016).
- Company
- Baxter Healthcare Corp.
- Recall Initiated
- May 23, 2016
- Posted
- June 24, 2016
- Terminated
- March 28, 2017
- Recall Number
- Z-2049-2016
- Quantity
- 10,054 units
- Firm Location
- Deerfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Presence of leaks near top of the PrismaSate bags
Distribution
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
Lot / Code Info
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).
Root Cause
Other
Action Taken
Baxter Healthcare Corporation sent an Urgent Product Recall communication to affected customers via U.S.P.S. first class mail on 05/23/2016.
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