Santanello Surgical LLC: Medical Device Recall in 2019 - (Recall #: Z-2237-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 10, 2019

Date Posted: August 21, 2019

Recall Number: Z-2237-2019

Event ID: 83051

Reason for Recall:

Lack of package integrity may compromise sterility

Status: Terminated

Product Quantity: 98

Code Information:

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

Distribution Pattern:

FL,OK, OH, NY, ME, MN, WI

Voluntary or Mandated:

Voluntary: Firm initiated