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.
FDA Recall Z-2680-2016 · Posted None
Recalling FirmWaismed Ltd
Recall StatusTerminated
Product CodeFMI
Date Initiated2016-08-18
Date Terminated2016-12-05
Product Quantity50
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.
Firm Action
The firm emailed the US Consignees on August 18, 2016 that they were conducting a recall on the NIO/A and NIO/P products. The US distributor shall contact the customers and will collect the products from each of the customers. The recalled products shall be moved to Storage quarantine within one week. The company shall keep track on the process and the recall efficacy.
Root Cause
Component design/selection
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.