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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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)
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Boston Scientific Corporation
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
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)
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0668-2020
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