Reported May 20, 2015 · Terminated

ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.

Arc Medical Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

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: Arc Medical Inc · 4296 Cowan Rd · Tucker, GA · 30084-4800

Is this the product you have?

  • ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.
Lot codes and dates
  • Product code6160
  • Batch number110208-50
Amount recalled
1810 units

Where it was sold

Why it was recalled

Outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled correctly.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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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 29, 2017 · Data as of Sep 19, 5:35 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.