Electrolase Hyfrecator(r) Electrodes - Sharp recall
ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION…
Why was Electrolase Hyfrecator(r) Electrodes - Sharp 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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)].
- Product
- ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION…
- Recalling firm
- ConMed Corporation
- Quantity
- Domestic Distribution: 97,450 units; Foreign Distribution: 6,800 units
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of China, Dubai and Indonesia.
- Recall date
- February 27, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)