Prismaflex recallZ-1833-2020 · Baxter Healthcare Corporation · initiated Feb 6, 2020
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 Corporation 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
Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.
FDA root cause category: Under Investigation by firm
What the company is doing
Baxter is asking customers to: 1. Operators may continue to safely use the Prismaflex control unit according to the warnings and cautions in the Prismaflex Operators Manual. 2. Complete the enclosed Baxter Customer Reply Form and return it to Baxter by either fax or email.
Recall details
- Recall number
- Z-1833-2020
- Status
- Terminated
- Initiated by the company
- Feb 6, 2020
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 133
- Product code
- KDI
- FDA submissions
- K072093, K110823
- Distribution
- Distribution in US, Puerto Rico
Product description
Prismaflex System, Prismaflex Control Unit
Code information (models, lots, serial numbers)
Product Code:955792; GTIN 07332414126766
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- PRISMAFLEX 7.21Gambro AB · Dialyzer, high permeability with or without sealed dialysate system2 recalls4 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 85007).
- Z-1829-2020 · TerminatedPrismaflex System, Prismaflex Control Unit
- Z-1831-2020 · TerminatedPrismaflex System, Prismaflex Control Unit
- Z-1832-2020 · TerminatedPrismaflex System, Prismaflex Control Unit
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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