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Open, Classified

HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.

FDA Recall Z-1154-2021 · Posted None

Recalling FirmBovie Medical Corporation
Recall StatusOpen, Classified
Product CodeGEI
Date Initiated2021-02-01
Product Quantity3862 units

Reason for Recall

There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.

Firm Action

The firm sent "URGENT MEDICAL DEVICE RECALL" (FA-2021-1) and response form to customers on February 1, 2021.

Root Cause

Device Design

Distribution Pattern

US Nationwide distribution in the states of CA and FL.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K161558Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating, Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-AspiratingBovie Medical Corporation · 2016-07-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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