FDA Medical Device Recalls (openFDA)
Arc Medical Inc: ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.
- Recall number
- Z-1596-2015
- Recalling firm
- Arc Medical Inc
- Product
- ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.
- Status
- Terminated
- Initiated
- 2015-02-19
- Posted
- 2015-05-09
- Terminated
- 2017-08-29
- Reason
- Outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled correctly.
- Root cause
- Process control
- Action
- Consignees were contacted by telephone on 02/19/2015.
- Quantity
- 1810 units
- Distribution
- Distributed in CA and NC.
- Lot, serial or model codes
- Product code: 6160, Batch number: 110208-50
- 510(k) numbers
- ["K903054"]
- PMA numbers
- not on file
- Product code
- BYD
- Firm FEI
- 1000111925
- Firm city
- Tucker
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28