ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION USA. Intended to be used as active RF electrodes for desiccation, fulguration and coagulation.
Reported: February 27, 2013 Initiated: January 28, 2013 #Z-0826-2013
Product Description
ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION USA. Intended to be used as active RF electrodes for desiccation, fulguration and coagulation.
Reason for Recall
Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products.
Details
- Recalling Firm
- ConMed Corporation
- Units Affected
- Domestic Distribution: 97,450 units; Foreign Distribution: 6,800 units
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of China, Dubai and Indonesia.
- Location
- Utica, NY
Frequently Asked Questions
What product was recalled? ▼
ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION USA. Intended to be used as active RF electrodes for desiccation, fulguration and coagulation.. Recalled by ConMed Corporation. Units affected: Domestic Distribution: 97,450 units; Foreign Distribution: 6,800 units.
Why was this product recalled? ▼
Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 27, 2013. Severity: Moderate. Recall number: Z-0826-2013.
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