Recall Z-1318-2018 ยท HKN Refractor, Manual, Non-Powered, Including Phoropter
Reliance Medical Products Inc
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.
| Date | Dec 6, 2017 |
| Status | Terminated |
| 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 |
| Root cause | Employee error |
| 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 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.