Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2649-2016 — BVX-450NR Bovie Precise 360 Handpiece 45cm, needle Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.

U.S. FDA — Device Enforcement · United States · 2016-07-18 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2649-2016
Date of alert: 2016-07-18
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Bovie Medical Corporation
Product category: device
Product type: Devices

Reported risk: The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-2649-2016 — BVX-450NR Bovie Precise 360 Handpiece 45cm, needle Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.

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