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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