Z-2331-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 17, 2024
- Initiation Date
- June 7, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14 units
Product Description
AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.
Reason for Recall
Potential sheath damage that could lead to tissue damage and/or track hemorrhage.
Distribution Pattern
Domestic: NY, OH, & DC.
Code Information
Model No. ASX9/130; UDI# 00850002332278; Lot No. 7336314.