Reported Feb 27, 2013 · Terminated
ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx…
ConMed Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ConMed Corporation · 525 French Road · Utica, NY · 13502
Is this the product you have?
- 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.
- Lot codes and dates
- Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain
- a lot code in the following format120917X 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)]
- Amount recalled
- Domestic Distribution: 97,450 units; Foreign Distribution: 6,800 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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