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Recall Observatory FDA recall evidence

Device 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.

Z-0113-2015

August 28, 2014

Class II

Product summary

Firm
Vygon Corporation
Event
Event 69204
Status
Terminated
Classification
Class II
Quantity
42250
Official record key
device-enforcement:Z-0113-2015

Official wording

Reason: 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.

Code information: Product code and lot numbers: Product Code: 896.038, with lot Numbers: 291113EE, 070214EE, 210314EE, 280314EE.

Distribution pattern: Worldwide Distribution - US including CA and Internationally to CA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.