Reported Mar 31, 2021 · Terminated
Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
Baxter Healthcare Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baxter Healthcare Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625
Is this the product you have?
- Prismaflex Control Unit - Product UsageUsed for Continuous Renal Replacement Therapy (CRRT)
- Lot codes and dates
1,226 of 1,226 codes
GTIN 07332414105266 (product code 11308)serial numbers PA9946PA9945PA9939PA9938PA9936PA9935PA9934PA9933PA9932PA9931PA9930PA9929PA9928PA9926PA9925PA9924PA9923PA9922PA9921PA9920PA9919PA9918PA9917PA9916PA9915PA9914PA9913PA9912PA9907PA9813PA9804PA9803PA9801PA9800PA9799PA9798PA9797PA9796PA9793PA9792PA9791PA9786PA9784PA9724PA9723PA9714PA9713PA9712PA9711PA9709PA9703PA9680PA9675PA9674PA9669PA9668PA9667PA9666PA9665
- Amount recalled
- 1225 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repositioning System) Pump Assembly, may lead to alarm situations during or after a system self-test.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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