Bovie J-Plasma Precise 360 Handpiece Recalled for Tip Separation Risk
Bovie Medical Corporation is recalling J-Plasma Precise 360 handpieces because the PEEK tip may separate and remain in patient tissue.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect where a component may be retained in patient tissue, which aligns with the rubric criteria for Severe severity involving significant injury risks or structural defects.
Plain-English summary
Bovie Medical Corporation is recalling 1,176 units of the J-Plasma Precise 360 Handpiece. This single-use, disposable medical device is used to deliver helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.
The recall is due to a potential risk that the PEEK tip of the handpiece may separate from the device and be retained in the patient's tissue. The affected units include catalog numbers BVX-330BR, BVX-330NR, BVX-450BR, and BVX-450NR, with all lot numbers manufactured since May 1, 2016, included in the recall.
The products were distributed worldwide, including nationwide in the United States and in various countries in Europe, the Middle East, and Asia. Healthcare providers and facilities that have used or possess these devices should stop using them and contact Bovie Medical Corporation for instructions on return or disposal.
The recalled product
- Product
- J-Plasma Precise 360, single use, disposable. The Bovie J-Plasma Precise 360 Handpiece is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparascopic surgical procedures.
- Manufacturer
- Bovie Medical Corporation
- Affected units
- 1,176
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 (3)
- Catalog Numbers: BVX-330BR
- BVX-330NR
- BVX-450BR
Distribution
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