Reported Jul 19, 2017 · Terminated
Nicolet¿ Elite¿ 2 MHz OB Probe, Non-Fetal Monitor, Model #: X1L007, Catalog Code: N200. Intended for non-invasive…
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 ProbeNon-Fetal MonitorModel #: X1L007
- Catalog CodeN200. 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 numbersCER0320, and CER0321
81 of 81 codes
CER0179CER0240CER0241CER0242CER0243CER0244CER0245CER0246CER0247CER0248CER0249CER0250CER0251CER0252CER0253CER0254CER0255CER0256CER0257CER0258CER0259CER0260CER0261CER0262CER0263CER0264CER0265CER0266CER0267CER0268CER0269CER0270CER0271CER0272CER0273CER0274CER0275CER0276CER0277CER0278CER0279CER0280CER0281CER0282CER0283CER0284CER0285CER0286CER0287CER0288CER0289CER0290CER0291CER0292CER0293CER0294CER0295CER0296CER0297CER0298
- 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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