Z-0180-04

ComfortGel Nasal Mask size large

Name: Z-0180-04 ComfortGel Nasal Mask size large
Creator: Respironics, Inc.
Published: 2003-09-29
License: https://open.fda.gov/license/

Respironics, Inc. / initiated 2003-09-29 / Terminated

FDA source

Respironics, Inc. began a recall of ComfortGel Nasal Mask size large on 2003-09-29. The reason FDA records is "product does not contain built in exhalation port". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0180-04
Status: Terminated
Initiated: 2003-09-29
Posted: 2003-12-10
Terminated: 2004-03-01
Recalling firm: Respironics, Inc.
Product: ComfortGel Nasal Mask size large
Product code: BZD Ventilator, Non-Continuous (Respirator)
Reason for recall: product does not contain built in exhalation port
FDA root cause: Other
Action: The recalling firm telephoned the direct accounts to inform them of the problem and the need to return the product.
Quantity in commerce: 5293 units
Distribution: The products were shipped to sleep centers nationwide and in Canada.
Product codes and lots: Part number 1009043; Lot numbers 030826, 030814, 030528, 030307, and 020822.

Product code BZD

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)