Reported Jul 19, 2017 · Terminated
Nicolet¿ Elite¿ 2 MHz OB Water Proof Probe, Model #: X1L008, Catalog Code: NW20. Intended for non-invasive support,…
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¿ 2 MHz OB Water Proof ProbeModel #: X1L008
- Catalog CodeNW20. 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 numbersCHR0160, and CHR0161
CHR0140CHR0141CHR0142CHR0143CHR0144CHR0145CHR0146CHR0147CHR0148CHR0149CHR0150CHR0151CHR0152CHR0153CHR0154CHR0155CHR0156CHR0157CHR0158CHR0159
- 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.
Want the full recall guide?
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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