CLASS II Device recall · Reported 21 Aug 2019 · FDA Enforcement Report
Vampiro V5001-minimally invasive poole suction sleeve recalled
Santanello Surgical is recalling Vampiro V5001-minimally invasive poole suction sleeve that is an accessory instrument to, distributed in 7 states. The recall was initiated on 10 Jun 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2237-2019
- FDA event ID
- 83051
- Recalling firm
- Santanello Surgical, Columbus, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Jun 2019
- FDA classified
- 9 Aug 2019
- Reported
- 21 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 10 Jun 2019 | Recall initiated by company | |
| 9 Aug 2019 | Classified by FDA | +60 days |
| 21 Aug 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of package integrity may compromise sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory instrument to ANY 5mm spot suction/irrigation catheter
Where it was distributed
FL,OK, OH, NY, ME, MN, WI
Questions about this recall
Why was it recalled?
Lack of package integrity may compromise sterility
Which lots are affected?
Lot: SAN1003 UDI: (01)00810805000026(10)SAN0003(17)160205
Where was it sold?
FL,OK, OH, NY, ME, MN, WI
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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