Pentax Medical C2 CryoBalloon Standard Focal Catheter recall
Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to be…
Why was Pentax Medical C2 CryoBalloon Standard Focal Catheter 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot/Serial numbers: 06152018-02, 06252018-03, 07062018-01, 07232018-02, 08102018-01, 08172018-06, 08292018-04, and 9172018-01.
- Product
- Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to be…
- Recalling firm
- PENTAX of America Inc
- Quantity
- 157 devices
- Distribution
- 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.
- Recall date
- May 22, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)