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
4,069 of 4,069 codes
GTIN 07332414073718 (Product code 107493)serial numbers PA0105PA0104PA0106PA0102PA0107PA0112PA0111PA0117PA0113PA0120PA0127PA0124PA0130PA0132PA0131PA0134PA0128PA0136PA0141PA0140PA0143PA0142PA0148PA0149PA0147PA0153PA0152PA0150PA0163PA0162PA0160PA0159PA0158PA0165PA0164PA0177PA0176PA0169PA0167PA0166PA0180PA0179PA0184PA0178PA0188PA0186PA0195PA0199PA0211PA0216PA0214PA0209PA0205PA0216PA0204PA0222PA0217PA0226PA0231
- Amount recalled
- 4946 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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