Z-0767-2017 Class II Terminated

Recalled by Firefly Medical, Inc. — Fort Collins, CO

Recall Details

Product Type
Devices
Report Date
December 21, 2016
Initiation Date
November 1, 2016
Termination Date
August 1, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
239

Product Description

IVEA 500A Intended for Med-Surg patient care.

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.

Distribution Pattern

Worldwide Distribution -- USA and Canada.

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.