Reported Dec 21, 2016 · Terminated

IVEA 500A Intended for Med-Surg patient care.

Firefly Medical, 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: Firefly Medical, Inc. · 320 E Vine Dr Ste 312 · Fort Collins, CO · 80524-2332

Is this the product you have?

  • IVEA 500A Intended for Med-Surg patient care.
Lot codes and dates
  • Product Part Number 16100. Serial Numbers 100200-101068, except for serial numbers within this range not released into final inventory for other reasons.
Amount recalled
239

Why it was recalled

The dowel pin could potentially slip out of its press fit, resulting in the product potentially slumping to one side which could cause the patient to stumble.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 1, 2017 · Data as of Sep 19, 6:03 PM UTC

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