PrismaSATE recallZ-2049-2016 · Baxter Healthcare Corp. · initiated May 23, 2016
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxter Healthcare Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Presence of leaks near top of the PrismaSate bags
FDA root cause category: Other
What the company is doing
Baxter Healthcare Corporation sent an Urgent Product Recall communication to affected customers via U.S.P.S. first class mail on 05/23/2016.
Recall details
- Recall number
- Z-2049-2016
- Status
- Terminated
- Initiated by the company
- May 23, 2016
- Posted by the FDA
- Jun 24, 2016
- Recalling firm
- Baxter Healthcare Corp.
- Quantity
- 10,054 units
- Product code
- KPO
- FDA submissions
- K072908
- 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
Product description
PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy
Code information (models, lots, serial numbers)
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).
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- PrismaSATE 105351Baxter International Inc. · DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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