Reported Sep 7, 2016 · Terminated
NIO-A / NIO-P is an instant IO access device comprises housing with spring load mechanism that injects a trocar needle…
Waismed Ltd.
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: Waismed Ltd · 10, Amal St · Rosh Haayin, N/A · N/A
Is this the product you have?
- NIO-A / NIO-P is an instant IO access device comprises housing with spring load mechanism that injects a trocar needle into the bone marrow of a patient and allows connection of syringe or IV administration set. The NIO-A is intended for adults above 12 years old and the NIO-P is intended for pediatric patients 3 - 12 years of age.
- Lot codes and dates
- 1620005
- Amount recalled
- 50
Where it was sold
Why it was recalled
WaisMed received a report in which during the operation of the NIO-A, the needle was not released from the device as expected. The device was placed on the floor and after several minutes the needle was released spontaneously. NIO-A and the NIO-P models have the same activation mechanism. However, none of the affected lots of the NIO-A are distributed in the US, and thus the company is only recalling a single lot of NIO-P in the US.
This product could cause temporary or reversible health problems — stop using it.
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