Waismed Recalls NIO-P Instant Intraosseous Access Devices Due to Malfunction
Waismed is recalling 50 units of NIO-P devices because a needle failed to release as expected during operation, posing a risk of injury.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a mechanical malfunction that poses a risk of harm (needle release failure), but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Waismed Ltd is recalling 50 units of the NIO-P instant intraosseous (IO) access device. The NIO-P is intended for pediatric patients aged 3 to 12 years and features a spring-loaded mechanism that injects a trocar needle into the bone marrow to allow for the connection of a syringe or IV administration set.
The recall was initiated after Waismed received a report that during the operation of the NIO-A model, 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. Although the NIO-A and NIO-P models share the same activation mechanism, the affected lots of the NIO-A are not distributed in the United States. Consequently, the company is only recalling a single lot of the NIO-P model within the US.
The affected units were distributed in Wisconsin, Texas, California, and Louisiana, as well as in numerous international locations including the UK, Canada, Australia, and various European and Asian countries. Consumers and healthcare providers should stop using the recalled NIO-P devices and contact Waismed for further instructions or a replacement.
The recalled product
- 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 i
- Manufacturer
- Waismed Ltd
- Affected units
- 50
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 1620005
Distribution
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