ThermoFlo 1 HME recall
ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.
Why was ThermoFlo 1 HME recalled?
Outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled correctly.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product code: 6160, Batch number: 110208-50
- Product
- ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.
- Recalling firm
- Arc Medical Inc
- Quantity
- 1810 units
- Distribution
- Distributed in CA and NC.
- Recall date
- May 20, 2015
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)