Z-0668-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 18, 2019
- Initiation Date
- November 18, 2019
- Termination Date
- June 25, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 179
Product Description
Habib EUS RFA, 20mm electrode active tip, Material Number/UPN: 6700 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radiofrequency generator.
Reason for Recall
During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the EUS-FNA needle. It was determined that capacitive 5 coupling presents a risk of energy transfer from the Habib EUS RFA active tip to the introducer device. This capacitive coupling could result in thermal injury to tissue outside of the targeted treatment area due to its use with an un-insulated EUS-FNA needle requiring little or no medical intervention.
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, CO, CT, FL, NJ, NY, MA, MD, MN, TN, TX and countries of Canada, India, Australia, Great Britain, Greece, Spain.
Code Information
Material Number/UPN: 6700 GTIN: 5060271140596 Batches: 17-C01 (Expiration: 10-Jul-2020), 17-C03 (Expiration: 12-Nov-2020), 17-C04 (Expiration: 18-Feb-2021), 17-C05 (Expiration: 18-Feb-2021), 17-C09 (Expiration: 19-Feb-2021)