Firefly Medical, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0767-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

IVEA 500A Intended for Med-Surg patient care.

Product Classification:

Class II

Date Initiated: November 1, 2016

Date Posted: December 21, 2016

Recall Number: Z-0767-2017

Event ID: 75571

Reason for Recall:

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.

Status: Terminated

Product Quantity: 239

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.

Voluntary or Mandated:

Voluntary: Firm initiated