Z-0424-05

Bio Med Devices Patient Breathing Circuit Catalog Number: 80015 Labeled in part: DO NOT REUSE DISPOSABLE...

Name: Z-0424-05 Bio Med Devices Patient Breathing Circuit Catalog Number: 80015 Labeled in part: DO NOT REUSE DISPOSABLE...
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 Bio Med Devices Patient Breathing Circuit Catalog Number: 80015 Labeled in part: DO NOT REUSE DISPOSABLE DISPOSABLE PATIENT BREATHING CIRCUIT... 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-0424-05
Status: Terminated
Initiated: 2004-12-06
Posted: 2005-01-29
Terminated: 2005-11-21
Recalling firm: Bio-Med Devices, Inc.
Product: Bio Med Devices Patient Breathing Circuit Catalog Number: 80015 Labeled in part: DO NOT REUSE DISPOSABLE DISPOSABLE PATIENT BREATHING CIRCUIT =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1-PATIENT SMOOTH BORE HOSE 1-ADAPTER 22mmx22mm 22mmIDx72'' w/CLIPS 1-ADULT PRESSURE TEE w/.140 HOLE 1-LINE 1/8''IDx84'' 1-TEE 1/8''x1/8''x1/8'' 1-LINE 1/8''IDx24'' 1-HOLDING ARM 1-LINE 1/8''IDx2'' 1-CUFF 1/4''IDx2''
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: 159 cs
Distribution: Nationwide Forign: Canada, Greece, Japna, Israel, Saudi Arabia,
Product codes and lots: Lot Numbers: Last 6 digits 09092304, 09092404, 05092704, 02092804 01092904, 05093004, 01100104, 01100404, 01100504, 01101104, 01101204, 01101404 01101804, 01102004, 01102104, 01102504 01102604, 09102704, 09102804, 09110104 09110204, 09110404, 05110804, 09111104 09111504, 01111604, 09111704, 09111804 02111904, 09112204, 09112304, 09112404 05112904, 09113004, 02120104, 09120204

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)