Z-0326-05

RemRest Non-Invasive Continuous Positive Airway Pressure System, Model 903. The firm name on the device is...

Name: Z-0326-05 RemRest Non-Invasive Continuous Positive Airway Pressure System, Model 903. The firm name on the device is...
Creator: Medical Industries America Inc
Published: 2004-09-03
License: https://open.fda.gov/license/

Medical Industries America, Inc. / initiated 2004-09-03 / Terminated

FDA source

Medical Industries America Inc began a recall of RemRest Non-Invasive Continuous Positive Airway Pressure System, Model 903. The firm name on the device is Medical Industries America Inc., Adel, IA on 2004-09-03. The reason FDA records is "Units could show an error code and stop functioning". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0326-05
Status: Terminated
Initiated: 2004-09-03
Posted: 2004-12-17
Terminated: 2005-08-18
Recalling firm: Medical Industries America, Inc.
Product: RemRest Non-Invasive Continuous Positive Airway Pressure System, Model 903. The firm name on the device is Medical Industries America Inc., Adel, IA.
Product code: BZD Ventilator, Non-Continuous (Respirator)
Reason for recall: Units could show an error code and stop functioning.
FDA root cause: Other
Action: The recall was initiated via telephone on 9/3/04 to their customers explaining the reason for recall and instructing them to hold the units for further instruction. A telephone call to the customers on 9/10/04 instructed them to return the units for correction and replacement and to notify the end users.
Quantity in commerce: 74 units
Distribution: Distribution was made to home health care providers located in LA, NC, NY, TX, MO, CO, IA, MA, WV, IL, and FL. Foreign distribution was made to Hong Kong, Chile, and Canada.
Product codes and lots: All serial numbers beginning with C0424

Product code BZD

K002763Class IIRemrestMedical Industries America, Inc. / cleared 2001-05-04

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)