Columbus, OH, United States
Santanello Surgical LLC recalls
1 recall recorded since 2018, most recently on 10 June 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 10 June 2019
- Terminated
- 13 January 2021
- Reason
- Lack of package integrity may compromise sterility
- Distribution
- FL,OK, OH, NY, ME, MN, WI
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2237-2019
- VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory instrument to ANY 5mm spot suction/irrigation catheter
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.