Z-1596-2015Class III

ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit

Name: Z-1596-2015 ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit
Creator: Arc Medical Inc
Published: 2015-02-19
License: https://open.fda.gov/license/

Arc Medical, Inc. / initiated 2015-02-19 / Terminated / root cause: manufacturing process

FDA source

Arc Medical Inc began a recall of ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit on 2015-02-19. FDA classified it as Class III and gives the reason as "Outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled correctly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1596-2015
Classification: Class III
Status: Terminated
Initiated: 2015-02-19
Posted: 2015-05-09
Terminated: 2017-08-29
Recalling firm: Arc Medical, Inc.
Product: ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.
Product code: BYD Condenser, Heat And Moisture (Artificial Nose)
Reason for recall: Outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled correctly.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees were contacted by telephone on 02/19/2015.
Quantity in commerce: 1810 units
Distribution: Distributed in CA and NC.
Product codes and lots: Product code: 6160, Batch number: 110208-50

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1596-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1596-2015	Class III	Terminated	Voluntary: Firm initiated	2015-05-20	2015-05-08

Product code BYD

K903054Class IHme-10 (Tm)Pharma Systems, Inc. / cleared 1990-10-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)