FDA-Device2016-12-21Class II

IVEA 500A Intended for Med-Surg patient care.

Firefly Medical, Inc.
Hazard

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.

Sold states
Worldwide Distribution -- USA and Canada.
Affected count
239
Manufactured in
320 E Vine Dr Ste 312, Fort Collins, CO, United States
Products
IVEA 500A Intended for Med-Surg patient care.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0767-2017

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief