FDAFDA · Food and drugs·Recall number Z-0113-2015
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.
Published October 29, 2014 · Recall initiated: August 28, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Vygon has uncovered potential problems with membrane elasticity in the 896.038, Bionector Needleless connector and is issuing a voluntary recall of the 896.038, Bionector Needleless connector.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Vygon Corporation
- Distributor
- Worldwide Distribution - US including CA and Internationally to CA.
- Lot
- Product code and lot numbers: Product Code: 896.038, with lot Numbers: 291113EE, 070214EE, 210314EE, 280314EE.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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