FDA Medical Device Recalls (openFDA)
Waismed Ltd: 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.
- Recall number
- Z-2680-2016
- Recalling firm
- Waismed Ltd
- 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.
- Status
- Terminated
- Initiated
- 2016-08-18
- Posted
- not on file
- Terminated
- 2016-12-05
- 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.
- Root cause
- Component design/selection
- 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.
- Quantity
- 50
- Distribution
- 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
- Lot, serial or model codes
- 1620005
- 510(k) numbers
- ["K160805"]
- PMA numbers
- not on file
- Product code
- FMI
- Firm FEI
- 3011989505
- Firm city
- Rosh Haayin
- Firm state
- not on file
- Firm country
- Israel
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28