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Recall Observatory FDA recall evidence

Device product

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

Z-2237-2019

June 10, 2019

Class II

Product summary

Firm
Santanello Surgical LLC
Event
Event 83051
Status
Terminated
Classification
Class II
Quantity
98
Official record key
device-enforcement:Z-2237-2019

Official wording

Reason: Lack of package integrity may compromise sterility

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

Distribution pattern: FL,OK, OH, NY, ME, MN, WI

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    package integrity may compromise
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    package integrity may compromise sterility