Velocity Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.
Reported: March 10, 2021 Initiated: February 1, 2021 #Z-1153-2021
Product Description
Velocity Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.
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.
Details
- Recalling Firm
- Bovie Medical Corporation
- Units Affected
- 5894 units
- Distribution
- US Nationwide distribution in the states of CA and FL.
- Location
- Clearwater, FL
Frequently Asked Questions
What product was recalled? ▼
Velocity Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.. Recalled by Bovie Medical Corporation. Units affected: 5894 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 10, 2021. Severity: Moderate. Recall number: Z-1153-2021.
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