Megadyne Recalls Suction Coagulators Due to Self-Activation Risk
Megadyne Medical Products is voluntarily recalling specific lots of Hand Control 12FR Suction Coagulators because they may self-activate when connected to a generator.
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 with a risk of unintended activation during surgery, which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the High severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Megadyne Medical Products, Inc. is voluntarily recalling 494 units of Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25. The affected units are identified by Lot Number 132405 and have an expiration date of 07-2018. These devices are intended to conduct monopolar electrosurgical energy and remove surgical smoke and fluids during ENT and general surgical procedures.
The recall is being conducted because a small number of these suction coagulators have the potential to self-activate immediately upon connection to the electrosurgical generator. If this occurs, the device may remain activated until it is disconnected from the generator.
The affected products were distributed in the United States, specifically in Florida, Minnesota, Louisiana, New Jersey, New Mexico, Pennsylvania, and Texas, as well as internationally to Canada. Healthcare facilities and users should stop using the affected devices immediately and contact Megadyne Medical Products for instructions on returning or disposing of the units.
The recalled product
- Product
- Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25, packaged Tyvek¿ polyester peel pouch, 25 pouches per box. This device is intended to conduct monopolar electrosurgical energy from an electrosurgical generator (ESU) to
- Manufacturer
- Megadyne Medical Products, Inc.
- Affected units
- 494
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 (1)
- Catalog Number: 0043-25 Lot Number: 132405 Exp. Date: 07-2018
Distribution
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