Z-2680-2016Class II

NIO-A / NIO-P is an instant IO access device comprises housing with spring load mechanism that injects a...

Name: Z-2680-2016 NIO-A / NIO-P is an instant IO access device comprises housing with spring load mechanism that injects a...
Creator: Waismed Ltd
Published: 2016-08-18
License: https://open.fda.gov/license/

Waismed Ltd. / initiated 2016-08-18 / Terminated / root cause: design

FDA source

Waismed Ltd began a recall of 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... on 2016-08-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2680-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-18
Posted: 2016-08-27
Terminated: 2016-12-05
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.
Product code: FMI Needle, Hypodermic, Single Lumen
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.
Root cause tag: design
FDA 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 in commerce: 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
Product codes and lots: 1620005

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2680-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2680-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-07	2016-08-27

Product code FMI

K160805Class IINio-PWaismed, Ltd. / cleared 2016-06-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)