OraSure Technologies, Inc. - Personelle OTC Skin Tag Remover - Class 3 Recall
Personelle OTC Skin Tag Remover, Canada Catalog Number: 1001-0314 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of skin tags. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 24, 2020 Category: Medical Devices Source Type: alerts
OraSure Technologies, Inc. - CVS Advanced Wart Remover Kit - Class 3 Recall
CVS Advanced Wart Remover Kit, Catalog Number: 1001-0407 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of common warts and plantar warts. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 24, 2020 Category: Medical Devices Source Type: alerts
OraSure Technologies, Inc. - Pointts sistema de ellmlnact!;o de verrugas OTC - Class 3 Recall
Pointts sistema de ellmlnact!;o de verrugas OTC - Brazil Catalog Number: 1001-0280 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of skin tags. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 24, 2020 Category: Medical Devices Source Type: alerts
PENTAX of America Inc - Pentax Medical C2 CryoBalloon Standard Focal Catheter - Class 2 Recall
Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s Esophagus. The system includes the following components: (1) CryoBalloon Catheter connects to the Controller, which controls the operation of the Catheter such as diffuser (sprayer) positioning and ablation (nitrous oxide release); (2) CryoBalloon Controller contains the cartridge heater and cryogen delivery valve, which is controlled...
Source: Medical Device Recalls - May 15, 2019 Category: Medical Devices Source Type: alerts
PENTAX of America Inc - Pentax Medical C2 CryoBalloon Standard 90 degree Catheter - Class 2 Recall
Pentax Medical C2 CryoBalloon Standard 90 degree Catheter, Model FG 1030, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s Esophagus. The system includes the following components: (1) CryoBalloon Catheter connects to the Controller, which controls the operation of the Catheter such as diffuser (sprayer) positioning and ablation (nitrous oxide release); (2) CryoBalloon Controller contains the cartridge heater and cryogen delivery valve, which is contro...
Source: Medical Device Recalls - May 15, 2019 Category: Medical Devices Source Type: alerts
PENTAX of America Inc - Pentax Medical C2 CryoBalloon Pear Focal Catheter - Class 2 Recall
Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s Esophagus. The system includes the following components: (1) CryoBalloon Catheter connects to the Controller, which controls the operation of the Catheter such as diffuser (sprayer) positioning and ablation (nitrous oxide release); (2) CryoBalloon Controller contains the cartridge heater and cryogen delivery valve, which is controlled wit...
Source: Medical Device Recalls - May 15, 2019 Category: Medical Devices Source Type: alerts
PENTAX of America Inc - C2 CryoBalloon Ablation System - Class 2 Recall
C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s Esophagus. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 2, 2019 Category: Medical Devices Source Type: alerts
C2 Therapeutics, Inc. - Catheter, C2 CryoBalloon Ablation System - Class 2 Recall
C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 6, 2018 Category: Medical Devices Source Type: alerts
C2 Therapeutics, Inc. - C2 CryoBalloon Ablation System - Class 2 Recall
C2 CryoBalloon Ablation System - Controller Cap. C2 CryoBalloon Controller; Cryosurgical Unit, Cryogenic Surgical Device The affected product is the Controller Cap component only, which is provided to the customer already assembled onto the Controller. Model number: FG-1012 Product Usage: The C2 CryoBalloon Ablation System is intended for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett s Esophagus with dysplasia. It is a cryosurgical system with a nitrous oxide cooled balloon that is compatible with a commercially available endoscope wit...
Source: Medical Device Recalls - March 16, 2017 Category: Medical Equipment Source Type: alerts
ACMI Corporation - Class 3 Recall
Cryo-Tip T-1910 Exo-Endocervical, Part Number 90501 (as labeled) for use with the Circon Cryomedics MT-700 Cryosurgical System (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 26, 2015 Category: Medical Equipment Source Type: alerts
CSA Medical - CSA Medical truFreeze Console - Class 2 Recall
CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device Model: CC3-01 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 24, 2015 Category: Medical Equipment Source Type: alerts
CSA Medical - CSA Medical truFreeze Spray Kit - Class 2 Recall
CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device Model: CC3-01 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 24, 2015 Category: Medical Equipment Source Type: alerts
CooperSurgical, Inc. - Class 2 Recall
WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with Pinned Yoke - Part Number 900019-70; LL100 Multi Tip W/TC - Part Number: 900629; LL100 - CO2 - Part Number 900162 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 17, 2015 Category: Medical Equipment Source Type: alerts
CSA Medical - CSA Medical trufreeze - Class 2 Recall
CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device ***The involved units are those with the newest version of a panel PC referred to as POC-127. These panels are identified by serial number. *** The truFreeze is intended for cryogenic destruction of tissue requiring either active or passive venting during surgical procedures. The truFreeze is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign and malignant lesions. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 8, 2015 Category: Medical Equipment Source Type: alerts
Atricure Inc - cryoICE cryoablation probe (CRYO2) - Class 2 Recall
Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pouches Product Usage: Cryogenic probe for cardiac ablation surgery. The CryoICE cryoablation probe is a sterile, single use device intended to use in the cryosurgical treatment of cardiac arrhythmias. The probe freezes target tissues, creating an inflammatory response (cryo-necrosis) that blocks the electrical conduction pathway. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 31, 2014 Category: Medical Equipment Source Type: alerts
