ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.
FDA device recall Z-1596-2015 · posted 2015-05-09 · Terminated
Recall details
- Recalling firm
- Arc Medical Inc
- Reason for recall
- Outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled correctly.
- Action taken
- Consignees were contacted by telephone on 02/19/2015.
- Root cause
- Process control
- Status
- Terminated
- Product code
- BYD
- Quantity affected
- 1810 units
- Distribution
- Distributed in CA and NC.
- Date initiated
- 2015-02-19
- Date posted
- 2015-05-09
- Date terminated
- 2017-08-29
- Location
- Tucker, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HME-10 (TM) (K903054) | Pharma Systems, Inc. | 1990-10-31 |