To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.
Megadyne Medical Products
20 recalls • • Categories: Other Medical Devices, Surgical Instruments, Infusion Pumps
To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.
To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.
Reports of patient burns.
Class I - Dangerous
Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients.
Class I - Dangerous
Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients.
Class I - Dangerous
Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients.
Class I - Dangerous
Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients.
An issue with the Suction Coagulator product family may lead to fluid ingress into the handpiece. Fluid ingress can lead to intermittent device activation, non-activation, or self-activation when plugged into the electrosurgery unit (ESU).
Class I - Dangerous
Firm has received reports of patient burns in surgical procedures where device was used.
Class I - Dangerous
Firm has received reports of patient burns in surgical procedures where device was used.
Class I - Dangerous
Firm has received reports of patient burns in surgical procedures where device was used.
Class I - Dangerous
Firm has received reports of patient burns in surgical procedures where device was used.
Class I - Dangerous
Firm has received reports of patient burns in surgical procedures where device was used.
Class I - Dangerous
Firm has received reports of patient burns in surgical procedures where device was used.
Class I - Dangerous
Firm has received reports of patient burns in surgical procedures where device was used.
Class I - Dangerous
Firm has received reports of patient burns in surgical procedures where device was used.
Class I - Dangerous
If two devices are plugged into the same channel/port in the generator, both devices activate. If one device is left laying on the patient, the result could be burning of the patient.
Megadyne Medical Products, Inc. is voluntarily recalling Hand Control 12Fr Suction Coagulator with 10ft cord and 132405 Holster, Sterile, Disposable, Lot 132405 due to the potential for a small number of these suction coagulators to self-activate immediately on connection to the electrosurgical generator and to remain activated until it is disconnected.
Megadyne Medical Products is recalling certain lots of E-Z Clean, L-Wire laproscopic Electrode Standard Stem and Split Stem due to potential breach of insulation.