The Recall Desk
ModerateFDA (Devices)·Z-2237-2019·Announced 2019-08-21

Santanello VAMPIRO V5001 Suction Sleeve Recalled for Package Integrity Issues

Santanello Surgical LLC is recalling 98 VAMPIRO V5001 suction sleeves because package integrity issues may compromise sterility.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a theoretical risk of compromised sterility due to packaging issues, with no reported injuries or illnesses.

Plain-English summary

Santanello Surgical LLC is recalling 98 units of the VAMPIRO V5001 minimally invasive poole suction sleeve. This accessory instrument is designed for use with 5mm spot suction/irrigation catheters. The recall is due to a lack of package integrity, which may compromise the sterility of the devices.

The affected units are identified by Lot SAN1003 and UDI (01)00810805000026(10)SAN0003(17)160205. The devices were distributed in Florida, Oklahoma, Ohio, New York, Maine, Minnesota, and Wisconsin.

Healthcare providers and patients should stop using the affected devices and contact Santanello Surgical LLC for further instructions.

The recalled product

Product
VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory instrument to ANY 5mm spot suction/irrigation catheter
Manufacturer
Santanello Surgical LLC
Category
Medical Device — Surgical Instrument
Hazard
Affected units
98

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot: SAN1003 UDI: (01)00810805000026(10)SAN0003(17)160205

Distribution

Distributed in 7 states:

Related recalls

Same hazard · sterility compromise

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