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Recall Observatory FDA recall evidence

Device product

J-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR

Z-1156-2018

February 08, 2018

Class II

Product summary

Firm
Bovie Medical Corporation
Event
Event 79398
Status
Terminated
Classification
Class II
Quantity
595 units
Official record key
device-enforcement:Z-1156-2018

Official wording

Reason: Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an incomplete helium seal. The potential exists for patient fluid backflow into the handpiece and the generator receptacle leading to risk of cross-contamination if the generator is reused.

Code information: All lots manufactured since 01/01/2014

Distribution pattern: worldwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an incomplete helium seal. The potential exists for patient fluid backflow into the handpiece and the generator receptacle leading to risk of cross-contamination if the generator is reused.