Reported Jul 19, 2017 · Terminated
Nicolet¿ Elite¿ 3 MHz OB Probe, Model #: X1L001, Catalog Code: N300. Intended for non-invasive support, i.e. early…
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¿ 3 MHz OB ProbeModel #: X1L001
- Catalog CodeN300. 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 numbersCAR0580, and CAR0600
1,706 of 1,706 codes
CAQ0100CAQ0101CAQ0102CAQ0103CAQ0104CAQ0105CAQ0106CAQ0107CAQ0108CAQ0109CAQ0110CAQ0111CAQ0112CAQ0113CAQ0114CAQ0115CAQ0116CAQ0117CAQ0118CAQ0119CAQ0120CAQ0121CAQ0122CAQ0123CAQ0124CAQ0125CAQ0126CAQ0127CAQ0128CAQ0129CAQ0130CAQ0131CAQ0132CAQ0133CAQ0134CAQ0135CAQ0136CAQ0137CAQ0138CAQ0139CAQ0140CAQ0141CAQ0142CAQ0143CAQ0144CAQ0145CAQ0146CAQ0147CAQ0148CAQ0149CAQ0150CAQ0151CAQ0152CAQ0153CAQ0154CAQ0155CAQ0156CAQ0157CAQ0158CAQ0159
- 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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