VAMPIRO V5001-minimally invasive poole suction sleeve that is an… — Class II medical device recall Z-2237-2019
Terminated recall by Santanello Surgical LLC, reported 2019-08-21, distributed in FL, ME, MN, NY, OH, OK, WI. Lack of package integrity may compromise sterility
| Recall number | Z-2237-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Santanello Surgical LLC, Columbus, OH, United States |
| Recall initiated | 2019-06-10 |
| Classified | 2019-08-09 |
| Reported by FDA | 2019-08-21 |
| Terminated | 2021-01-13 |
| Distributed | FL, ME, MN, NY, OH, OK, WI |
| Quantity | 98 |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 00810805000026 |
| Lot numbers | SAN1003 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2237-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.