ConMed Recalls Electrolase Hyfrecator Electrodes Due to Compromised Sterile Pouch Seals
ConMed is recalling Electrolase Hyfrecator electrodes because some sterile pouch seals were compromised, potentially affecting sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where the sterile barrier was compromised, creating a risk of infection or harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
ConMed Corporation is recalling Electrolase Hyfrecator electrodes, catalog number 7-100-8BX. These are disposable, sterile, prescription-only tips intended to be used as active RF electrodes for desiccation, fulguration, and coagulation.
The recall was initiated because 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 could impact the sterility of the devices.
The affected lot codes range from 120628X to 120917X. The recall covers 97,450 units distributed domestically in the United States and 6,800 units distributed in China, Dubai, and Indonesia. Users should stop using the affected products and contact ConMed for further instructions.
The recalled product
- Product
- 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.
- Manufacturer
- ConMed Corporation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Beginning Lot Code 120628X
- 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)].
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by ConMed Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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