The Recall Desk

FDA (Devices) recall action 82274

PENTAX of America Inc recalled 3 products on 2019-05-22

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2019-05-22
Critical
0
Units
229

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2019-05-22

    Pentax Medical C2 CryoBalloon Catheter Recalled for Dose Transmission Errors

    Pentax of America Inc is recalling 68 C2 CryoBalloon Pear Focal Catheters because incorrect default doses and increments may be transmitted to the controller if the RFID tag is not correctly readable.

    Product
    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 dysplast
    Category
    Distribution
    17 states
  • HighFDA (Devices)··2019-05-22

    Pentax Medical C2 CryoBalloon Catheter Recalled for Dose Transmission Error

    PENTAX of America Inc is recalling 4 C2 CryoBalloon Catheters because incorrect default doses and increments may be transmitted to the controller if the RFID tag is not correctly readable.

    Product
    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
    Category
    Distribution
    17 states
  • HighFDA (Devices)··2019-05-22

    Pentax Medical C2 CryoBalloon Catheter Recalled for Dose Transmission Errors

    Pentax of America Inc is recalling 157 C2 CryoBalloon Standard Focal Catheters because incorrect default doses and increments may be transmitted to the controller if the RFID tag is not correctly readable.

    Product
    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 dysp
    Category
    Distribution
    17 states