Reported Jul 19, 2017 · Terminated
Nicolet¿ Elite¿ 5 MHz Vascular Probe, Model #: X1L004, Catalog Code: N500. Intended for non-invasive support, i.e.…
Natus Neurology Inc.
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: Natus Neurology Inc · 3150 Pleasant View Rd · Middleton, WI · 53562-4800
Is this the product you have?
Nicolet¿ Elite¿ 5 MHz Vascular ProbeModel #: X1L004
- Catalog CodeN500. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc
- Lot codes and dates
- Serial numbersCBR0314, and CBR0315
524 of 524 codes
CBQ0302CBQ0344CBQ0385CBQ0386CBQ0387CBQ0388CBQ0389CBQ0390CBQ0391CBQ0392CBQ0393CBQ0394CBQ0395CBQ0396CBQ0397CBQ0398CBQ0399CBQ0400CBQ0401CBQ0402CBQ0403CBQ0404CBQ0410CBQ0411CBQ0412CBQ0413CBQ0414CBQ0415CBQ0416CBQ0417CBQ0418CBQ0419CBQ0420CBQ0421CBQ0422CBQ0423CBQ0424CBQ0425CBQ0426CBQ0427CBQ0428CBQ0429CBQ0430CBQ0431CBQ0432CBQ0433CBQ0434CBQ0435CBQ0436CBQ0437CBQ0438CBQ0439CBQ0440CBQ0441CBQ0442CBQ0443CBQ0444CBQ0445CBQ0446CBQ0447
- Serial numbers
- Amount recalled
- 2,335 units total
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
Why it was recalled
Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear heart rate and/or blood flow.
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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