Z-2237-2019 Class II Terminated
FDA device recall Z-2237-2019 was initiated by Santanello Surgical LLC on June 10, 2019 and is designated Class II. Reason for recall: Lack of package integrity may compromise sterility The recall status is terminated (terminated January 13, 2021). Affected quantity: 98.
Recall Details
- Product Type
- Devices
- Report Date
- August 21, 2019
- Initiation Date
- June 10, 2019
- Termination Date
- January 13, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 98
Product Description
VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory instrument to ANY 5mm spot suction/irrigation catheter
Reason for Recall
Lack of package integrity may compromise sterility
Distribution Pattern
FL,OK, OH, NY, ME, MN, WI
Code Information
Lot: SAN1003 UDI: (01)00810805000026(10)SAN0003(17)160205