C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Class I - DangerousWhat Should You Do?
- Check if you have this product: Brazilian OPS Manual P/N 60905780
- 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:
- Integra LifeSciences Corp.
- Reason for Recall:
- The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Product Codes/Lot Numbers:
Brazilian OPS Manual P/N 60905780
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0637-2020
Related Recalls
AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catalog Number): (1) ASX15/60 and (2) ASX15/80
Integra LifeSciences
Class I - Dangerous
Possibility for the obturator to break (separate).
Potential that the induction seal is not completely sealed to the device tube packaging.
Class I - Dangerous
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.