Events

Recall of Device Recall Refractor Suspension Arm (P/N: 525004, 05 and 525006, 07)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Reliance Medical Products Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79601
  • Event Risk Class
    Class 2
  • Event Number
    Z-1318-2018
  • Event Initiated Date
    2017-12-06
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162749
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Refractor, manual, non-powered, including phoropter - Product Code HKN
  • Reason
    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.
  • Action
    Recalling firm sent letter to customers via certified mail for US customers and via regular mail to foreign customers. Verify product has the presence of the one or more of the three parts: Refractor Suspension Arm missing Screw, Washer and/or Retaining Ring (Snap Ring) that may be missing, and to assure it is functioning properly. For further questions, please call (513) 398-3937

Device

Device Recall Refractor Suspension Arm (P/N: 525004, 05 and 525006, 07)
  • Model / Serial
    Model Number: 525004, 05 and 525006, 07
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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.
  • 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.
  • Manufacturer
    Reliance Medical Products Inc

Manufacturer

Reliance Medical Products Inc
  • Manufacturer Address
    Reliance Medical Products Inc, 3535 Kings Mills Rd, Mason OH 45040-2303
  • Manufacturer Parent Company (2017)
    Metall Zug AG
  • Source
    USFDA