FDA Medical Device Recalls (openFDA)
Santanello Surgical LLC: VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory instrument to ANY 5mm spot suction/irrigation catheter
- Recall number
- Z-2237-2019
- Recalling firm
- Santanello Surgical LLC
- Product
- VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory instrument to ANY 5mm spot suction/irrigation catheter
- Status
- Terminated
- Initiated
- 2019-06-10
- Posted
- not on file
- Terminated
- 2021-01-13
- Reason
- Lack of package integrity may compromise sterility
- Root cause
- Package design/selection
- Action
- Santanello Surgical issued recall letter dated 6/10/19 stating reason for recall, health risk and action to take: immediately examine inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Email contact@vampirosuction.com for return shipment procedures and reimbursement process. Questions call Santanello Surgical at 614-955-1832.
- Quantity
- 98
- Distribution
- FL,OK, OH, NY, ME, MN, WI
- Lot, serial or model codes
- Lot: SAN1003 UDI: (01)00810805000026(10)SAN0003(17)160205
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JOL
- Firm FEI
- 3013555389
- Firm city
- Columbus
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28