PENTAX of America Inc recalls Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, Sterile, RX. Product Usage: The C2 CryoBalloon Ab…

Recall date

December 3, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1325-2019

FDA classification

Class II

Brand / firm

PENTAX of America Inc

Sold / distributed

Distribution was made to CA, DC, FL, LA, MA, MD, MN, NC, NJ, NY, OH, PA, SC, TN, TX, VA, and WA. There was no government/military distribution. Foreign distribution was made to Canada, Germany, and the Netherlands.

Why it was recalled

Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the controller.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 with the foot pedal; (3) Foot Pedal; and (4) CryoBalloon Cartridge containing 36 grams of nitrous oxide.