FDAFDA · Food and drugs·Recall number Z-0826-2013
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.
Published February 27, 2013 · Recall initiated: January 28, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ConMed Corporation
- Distributor
- Worldwide Distribution-USA (nationwide) and the countries of China, Dubai and Indonesia.
- Lot
- Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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