Recall Z-2237-2019— Santanello Surgical LLC
Class II · Terminated
Class II FDA medical device recall by Santanello Surgical LLC, initiated 2019-06-10, terminated 2021-01-13. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.
- Recalling firm
- Santanello Surgical LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-06-10
- Terminated
- 2021-01-13
- Firm location
- Columbus, OH, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.