FDA Enforcement
Class II
Terminated
VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory instrument to ANY 5mm spot suction/irrigation catheter
Recall: Z-2237-2019
·
Reported August 21, 2019
Enforcement
- Recall Number
- Z-2237-2019
- Event ID
- 83051
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Santanello Surgical LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 21, 2019
- Initiation Date
- June 10, 2019
- Classification Date
- August 9, 2019
- Termination Date
- January 13, 2021
- Address
- 4664 Hayden Run Rd, N/A, Columbus, OH, 43221-5937, United States
Description
VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory instrument to ANY 5mm spot suction/irrigation catheter
Reason
Lack of package integrity may compromise sterility
Code Info
Lot: SAN1003 UDI: (01)00810805000026(10)SAN0003(17)160205
Distribution
FL,OK, OH, NY, ME, MN, WI
Quantity
98