Z-2680-2016 Class II Terminated
FDA device recall Z-2680-2016 was initiated by Waismed Ltd on August 18, 2016 and is designated Class II. Reason for recall: 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 w… The recall status is terminated (terminated December 5, 2016). Affected quantity: 50.
Recall Details
- Product Type
- Devices
- Report Date
- September 7, 2016
- Initiation Date
- August 18, 2016
- Termination Date
- December 5, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50
Product Description
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.
Reason for Recall
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.
Distribution Pattern
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
Code Information
1620005