Bovie Precise 360 Handpiece Recalled Due to Adhesive Bonding Defect
Bovie Medical Corporation is recalling 95 units of the BVX-330BR Bovie Precise 360 Handpiece because the adhesive bond to the angled tip may be incomplete.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a structural defect in a surgical device that could lead to device failure during a procedure. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
Bovie Medical Corporation is recalling 95 units of the BVX-330BR Bovie Precise 360 Handpiece, 33cm, blade. This medical device is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.
The recall is due to a manufacturing defect where the adhesive may be inadequately applied or the assembly may be manipulated after application, resulting in an incomplete bond to the angled tip. The affected units are from lots 0316D, 0416L, and 0516B.
The affected units were distributed worldwide, including in the United States (Maryland, Georgia, Missouri, and Florida) and Finland. Healthcare facilities and users should stop using the affected devices and contact Bovie Medical Corporation for instructions on return or replacement.
The recalled product
- Product
- BVX-330BR Bovie Precise 360 Handpiece 33cm, blade Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.
- Manufacturer
- Bovie Medical Corporation
- Affected units
- 95
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)
- Lot 0316D
- 0416L
- and 0516B.
Distribution
Part of a larger recall action
This product is one of 4 recalled by Bovie Medical Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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