FDA-Device2014-10-29Class II

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.

Vygon Corporation
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.

Sold states
Worldwide Distribution - US including CA and Internationally to CA.
Affected count
42250
Manufactured in
2750 Morris Rd Ste A200, Lansdale, PA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0113-2015

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