Recall Z-2680-2016— Waismed Ltd

Name: FDA recall Z-2680-2016
Creator: U.S. Food and Drug Administration
Published: 2016-08-18

Class II · Terminated

Class II FDA medical device recall by Waismed Ltd, initiated 2016-08-18, terminated 2016-12-05. It names one FDA 510(k) clearance: K160805. 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.. Reason: 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..

Recalling firm: Waismed Ltd
Classification: Class II
Status: Terminated
Initiated: 2016-08-18
Terminated: 2016-12-05
Firm location: Rosh Haayin, N/A, Israel

510(k) clearances named in this recall

1 on FDA's record

K160805 — NIO-PWaismed, Ltd.·cleared 2016-06-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.