Z-2237-2019Class II

VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory instrument to ANY 5mm spot...

Name: Z-2237-2019 VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory instrument to ANY 5mm spot...
Creator: Santanello Surgical LLC
Published: 2019-06-10
License: https://open.fda.gov/license/

Santanello Surgical LLC / initiated 2019-06-10 / Terminated / root cause: packaging

FDA source

Santanello Surgical LLC began a recall of VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory instrument to ANY 5mm spot suction/irrigation catheter on 2019-06-10. FDA classified it as Class II and gives the reason as "Lack of package integrity may compromise sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2237-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-10
Posted: 2019-08-09
Terminated: 2021-01-13
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
Product code: JOL Catheter And Tip, Suction
Reason for recall: Lack of package integrity may compromise sterility
Root cause tag: packaging
FDA 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 [email protected] for return shipment procedures and reimbursement process. Questions call Santanello Surgical at 614-955-1832.
Quantity in commerce: 98
Distribution: FL,OK, OH, NY, ME, MN, WI
Product codes and lots: Lot: SAN1003 UDI: (01)00810805000026(10)SAN0003(17)160205

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2237-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2237-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-09

Product code JOL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)