Reported Apr 18, 2018 · Terminated
Refractor Suspension Arm (P/N: 525004, 05 and 525006, 07) The Intended use of this medical device, as part of system to…
Reliance Medical Products Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Reliance Medical Products Inc · 3535 Kings Mills Rd · Mason, OH · 45040-2303
Is this the product you have?
- Refractor Suspension Arm (P/N525004, 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
- Lot codes and dates
- Model Number
52500405 and 52500607
- Model Number
- Amount recalled
- 933 ( of which 97 has been quarantined)
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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