C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Class I - DangerousWhat Should You Do?
- Check if you have this product: US Ops Manual P/N 60905769
- 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 Operator s 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:
US Ops Manual P/N 60905769
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0613-2020
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.