Recalls / —
—#179921
Product
Prismaflex System, Prismaflex Control Unit
- FDA product code
- KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- 510(k) numbers
- K072093, K110823
- Affected lot / code info
- Product Code:955792; GTIN 07332414126766
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.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
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.
Recalling firm
- Firm
- Baxter Healthcare Corporation
- Address
- 1 Baxter Pkwy, Deerfield, Illinois 60015-4625
Distribution
- Distribution pattern
- Distribution in US, Puerto Rico
Timeline
- Recall initiated
- 2020-02-06
- Terminated
- 2021-06-01
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #179921. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.