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Instrumed International Recalls
38 recalls on record · October 8, 2014 to December 17, 2014 · Medical Devices
October 8, 2014Medical DevicesFDA
Instrumed International, Inc. recalls Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to
Hazard: Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes. and 2) For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years.
October 8, 2014Medical DevicesFDA
Instrumed International, Inc. recalls Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to
Hazard: Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes. and 2) For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years.
October 8, 2014Medical DevicesFDA
Instrumed International, Inc. recalls Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to
Hazard: Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes. and 2) For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years.
October 8, 2014Medical DevicesFDA
Instrumed International, Inc. recalls Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to
Hazard: Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes. and 2) For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years.
October 8, 2014Medical DevicesFDA
Instrumed International, Inc. recalls Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to
Hazard: Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes. and 2) For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years.
October 8, 2014Medical DevicesFDA
Instrumed International, Inc. recalls Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to
Hazard: Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes. and 2) For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years.
October 8, 2014Medical DevicesFDA
Instrumed International, Inc. recalls Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to
Hazard: Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes. and 2) For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years.
October 8, 2014Medical DevicesFDA
Instrumed International, Inc. recalls Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to
Hazard: Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes. and 2) For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years.