FDA Device recall Z-2237-2019
VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory instrument to ANY 5mm spot suction/irrigation catheter
- FDA Device
- Class II
- terminated
- Published 2019-08-21
On 2019-08-21 the FDA classified a Class II recall of VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory instrument to ANY 5mm spot suction/irrigation catheter by Santanello Surgical, citing lack of package integrity may compromise sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2237-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-10 |
| Published | 2019-08-21 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Santanello Surgical |
| Distribution | FL, ME, MN, NY, OH, OK, WI |
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
Identifiers
| code_info | Lot: SAN1003 UDI: (01)00810805000026(10)SAN0003(17)160205 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2237-2019%22
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