Recall Z-1318-2018— Reliance Medical Products Inc
Class II · Terminated
Class II FDA medical device recall by Reliance Medical Products Inc, initiated 2017-12-06, terminated 2019-05-02. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-12-06
- Terminated
- 2019-05-02
- Firm location
- Mason, OH, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.