FDA recall Z-2237-2019
Santanello Surgical LLC · Class II · device
Product
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
FL,OK, OH, NY, ME, MN, WI
Key facts
- Status
- Terminated
- Initiation date
- 2019-06-10
- Report date
- 2019-08-21
- Termination date
- 2021-01-13
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Columbus, OH, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2237-2019