Reported May 16, 2018 · Terminated
NvisionVLE¿ Low-Profile Optical Probe; Catalog Numbers: 95501-LP and 95501-LP-5; UDI Information:…
Ninepoint Medical 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: Ninepoint Medical Inc. · 12 Oak Park Dr · Bedford, MA · 01730-1443
Is this the product you have?
3 of 3 products
| # | Barcodes | Product as published |
|---|---|---|
| 1 | NvisionVLE¿ Low-Profile Optical Probe | |
| 2 | Catalog Numbers: 95501-LP and 95501-LP-5 | |
| 3 | 008595910061880085959100618800859591006188 | UDI Information: (01)00859591006188(17)180531(10)005196), (01)00859591006188(17)180731(10)005251), (01)00859591006188(17)180930(10)005275) Product Usage: The NvisionVLE Low-Profile Optical Probe is intended to be used for imaging the micro-structure of human tissue. When used with the NvisionVLE Imaging System it provides two-dimensional, cross-sectional, real-time depth visualization. |
- Lot codes and dates
- Lot Numbers
005196005251005275
- Lot Numbers
- Amount recalled
- 152
Where it was sold
Why it was recalled
Distal tips of the probes may detach from the probe shaft during use.
This product could cause temporary or reversible health problems — stop using it.
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