CLASS III Device recall · Reported 20 May 2015 · FDA Enforcement Report
ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17 recalled
Arc Medical is recalling ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17, distributed in California, North Carolina. The recall was initiated on 19 Feb 2015 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1596-2015
- FDA event ID
- 70662
- Recalling firm
- Arc Medical, Tucker, GA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 19 Feb 2015
- FDA classified
- 8 May 2015
- Reported
- 20 May 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 19 Feb 2015 | Recall initiated by company | |
| 8 May 2015 | Classified by FDA | +78 days |
| 20 May 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled correctly.
Product as listed by the FDA
ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.
Where it was distributed
Distributed in CA and NC.
Questions about this recall
Why was it recalled?
Outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled correctly.
Which lots are affected?
Product code: 6160, Batch number: 110208-50
Where was it sold?
Distributed in CA and NC.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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