The Recall Desk
SevereFDA (Devices)·Z-1318-2018·Announced 2018-04-18

Reliance Medical Products Recalls Refractor Suspension Arms Due to Missing Parts

Reliance Medical Products is recalling 933 Refractor Suspension Arms because missing parts caused the device to fall on a patient.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a reported incident where the device fell on a patient's lower torso, meeting the criteria for a Severe rating due to significant injury reports.

Plain-English summary

Reliance Medical Products Inc is recalling 933 units of Refractor Suspension Arms (P/N: 525004, 05 and 525006, 07). The recall was initiated after the firm was notified by a distributor that a Refractor Suspension Arm fell on a patient's lower torso along with the arm housing. The product has been found with a missing Washer, Retaining Ring, and/or Stop Screw.

The affected devices are intended to store and position ophthalmological examination and diagnostic equipment, specifically a refractor. The recall covers units distributed worldwide, including nationwide distribution in the United States to the states of NJ, CA, OH, VA, MA, MN, IL, UT, TN, AR, LA, AZ, PA, TX, IA, and HI, as well as to Costa Rica, Jamaica, South Africa, New Zealand, South Korea, Dubai, Saudi Arabia, and Jordan. Of the 933 units, 97 have been quarantined.

Healthcare facilities and distributors should stop using the affected Refractor Suspension Arms immediately. Users should contact Reliance Medical Products Inc for instructions on how to return the devices or obtain replacements.

The recalled product

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.
Manufacturer
Reliance Medical Products Inc
Category
Medical Device — Ophthalmological Equipment
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Model Number: 525004
  • 05 and 525006
  • 07

Distribution

Distributed nationwide across the United States.

The notice also names 16 states specifically:

Related recalls

Same hazard · falling object

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