AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model No. ASX9/130; UDI# 00850002332278; Lot No. 7336314.
- 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:
- Potential sheath damage that could lead to tissue damage and/or track hemorrhage.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.
Product Codes/Lot Numbers:
Model No. ASX9/130; UDI# 00850002332278; Lot No. 7336314.
Distribution:
Distributed in: NY, OH, DC
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2331-2024
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
Possibility for the obturator to break (separate).
Potential that the induction seal is not completely sealed to the device tube packaging.
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.