Refractor Suspension Arm (P/N: 525004, 05 and 525006, 07) The Intended use of this medical ...
FDA Recall #Z-1318-2018 — Class II — December 6, 2017
Product Description
Refractor Suspension Arm (P/N: 525004, 05 and 525006, 07) The Intended use of this medical device, as part of system to store and position ophthalmological examination and diagnostic equipment, is to store and position for examination a device commonly known as a refractor.
Reason for Recall
Product has been found with a missing Washer, Retaining Ring, and/or Stop Screw. Recalling firm was notified by distributor that Refractor Suspension Arm fell on a patient s lower torso along with the arm housing
Recalling Firm
Reliance Medical Products Inc — Mason, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
933 ( of which 97 has been quarantined)
Distribution
Worldwide Distribution - USA(nationwide) Distribution to the states of : NJ, CA, OH, VA, MA, MN, IL , UT, TN, AR, LA, AZ, PA, TX, IA and HI., and to the countries of : Costa Rica, Jamaica, South Africa, New Zealand, South Korea, Dubai, Saudi Arabia and Jordan.
Code Information
Model Number: 525004, 05 and 525006, 07
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.