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Recall Observatory FDA recall evidence

Device product

IVEA 500A Intended for Med-Surg patient care.

Z-0767-2017

November 01, 2016

Class II

Product summary

Firm
Firefly Medical, Inc.
Event
Event 75571
Status
Terminated
Classification
Class II
Quantity
239
Official record key
device-enforcement:Z-0767-2017

Official wording

Reason: The dowel pin could potentially slip out of its press fit, resulting in the product potentially slumping to one side which could cause the patient to stumble.

Code information: Product Part Number 16100. Serial Numbers 100200-101068, except for serial numbers within this range not released into final inventory for other reasons.

Distribution pattern: Worldwide Distribution -- USA and Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The dowel pin could potentially slip out of its press fit, resulting in the product potentially slumping to one side which could cause the patient to stumble.