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U.S. Department of Health and Human Services

Class 2 Device Recall Refractor Suspension Arm (P/N: 525004, 05 and 525006, 07)

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 Class 2 Device Recall Refractor Suspension Arm (P/N: 525004, 05 and 525006, 07)see related information
Date Initiated by FirmDecember 06, 2017
Create DateApril 09, 2018
Recall Status1 Terminated 3 on May 02, 2019
Recall NumberZ-1318-2018
Recall Event ID 79601
Product Classification Refractor, manual, non-powered, including phoropter - Product Code HKN
ProductRefractor 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.
Code Information Model Number: 525004, 05 and 525006, 07
Recalling Firm/
Manufacturer		 Reliance Medical Products Inc
3535 Kings Mills Rd
Mason OH 45040-2303
For Additional Information Contact
513-398-3937
Manufacturer 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
FDA Determined
Cause 2		Employee error
ActionRecalling 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
Quantity in Commerce933 ( of which 97 has been quarantined)
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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