Vygon Recalls Bionector Needleless Connectors Due to Membrane Elasticity Issues
Vygon is voluntarily recalling Bionector Needleless connectors due to potential problems with membrane elasticity. The recall affects 42,250 units distributed worldwide.
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 potential functional defect (membrane elasticity) that could impact patient safety, but the source text explicitly states no illnesses or injuries have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Vygon Corporation is issuing a voluntary recall of the Bionector Needleless connector, product code 896.038. The recall is being conducted due to potential problems with membrane elasticity in the device. The Bionector is a multi-purpose catheter accessory that functions as a closed needle-less system for blood sampling, intermittent injection, and continuous infusion of fluids or medications in hospital or homecare settings.
A total of 42,250 units are affected by this recall. The specific lot numbers involved are 291113EE, 070214EE, 210314EE, and 280314EE. The product was distributed worldwide, including in the United States and Canada.
The source text does not specify any reported illnesses, injuries, or deaths associated with this recall. Consumers and healthcare providers should check their inventory for the affected product code and lot numbers and contact Vygon Corporation for further instructions on how to return or dispose of the devices.
The recalled product
- Product
- Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; a closed needle-less system permitting blood sampling, intermit ant injection and continuous infusion of fluids or medications to patients in a hospital or homecare situation.
- Manufacturer
- Vygon Corporation
- Hazard
- Affected units
- 42,250
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 (5)
- Product code and lot numbers: Product Code: 896.038
- with lot Numbers: 291113EE
- 070214EE
- 210314EE
- 280314EE.
Distribution
Distributed in 1 state:
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