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Waismed Ltd recalls NIO-A / NIO-P is an instant IO access device comprises housing with spring load mechanism that injects a trocar needle i
Recalled September 7, 2016 · FDA recall Z-2680-2016 · Waismed
Hazard
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. · FDA Class II
Units
50
Sold at
WI, TX, CA, LA and the following countries: UK, Spain, Poland, Israel, Czech Republic, France, Belgium, Denmark, Italy, Cyprus, Austria, Greece, Slovenia, Australia, Germany, Estonia, New Zealand, Switzerland, Costa Rica, Guatemala, Canada, Malaysia, Poland, Singapore, Lithuania, Romania
Description
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.
Product
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.
Manufacturer(s)
Waismed Ltd
Made in
Israel
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →