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Recall Observatory FDA recall evidence

Device product

Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous introduction of a guidewire or catheter into the vascular system, Catalog Number: 06597035 UPN: H787065970355

Z-0418-2021

October 14, 2020

Class II

Product summary

Firm
Angiodynamics, Inc.
Event
Event 86627
Status
Terminated
Classification
Class II
Quantity
32 kits
Official record key
device-enforcement:Z-0418-2021

Official wording

Reason: 5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator component

Code information: Lot Number: 5626935 Expiration Date: 08/31/2023

Distribution pattern: US Nationwide distribution including in the states of AL, CT, GA, FL.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator component