Z-0428-05

Pneumotach, Disposable (B) Catalog Number: 4408 Labeled in part: SINGLE USE CATALOG NO.4408 PNEUMOTACH...

Name: Z-0428-05 Pneumotach, Disposable (B) Catalog Number: 4408 Labeled in part: SINGLE USE CATALOG NO.4408 PNEUMOTACH...
Creator: Bio-Med Devices, Inc.
Published: 2004-12-06
License: https://open.fda.gov/license/

Bio-Med Devices, Inc. / initiated 2004-12-06 / Terminated

FDA source

Bio-Med Devices, Inc. began a recall of Pneumotach, Disposable (B) Catalog Number: 4408 Labeled in part: SINGLE USE CATALOG NO.4408 PNEUMOTACH, DISPOSABLE (B) =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=... on 2004-12-06. The reason FDA records is "Adapters may be occluded potentially preventing inhalation". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0428-05
Status: Terminated
Initiated: 2004-12-06
Posted: 2005-01-29
Terminated: 2005-11-21
Recalling firm: Bio-Med Devices, Inc.
Product: Pneumotach, Disposable (B) Catalog Number: 4408 Labeled in part: SINGLE USE CATALOG NO.4408 PNEUMOTACH, DISPOSABLE (B) =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1- PNEUMOTACH HEAD ASSEMBLY 1- PARATUBE 60'' 2- TUBING FITTINGS 1- 22x22mm ADAPTER
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Adapters may be occluded potentially preventing inhalation
FDA root cause: Other
Action: Bio-Med Devices issued recall notifcation by fax on 12/7/04. Accounts are requested to discontine use and return product. A Press Release issued to AP 12/8/04
Quantity in commerce: 107 cs
Distribution: Nationwide Forign: Canada, Greece, Japna, Israel, Saudi Arabia,
Product codes and lots: Lot Numbers: 05092204, 05101104, 05101304, 05101404 05102004, 05102604, 05102804, 05110204 05110304, 05110904, 05111804, 05112404 05120104

Product code CBK

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)