Bio Med Devices Patient Breathing Circuit Catalog Number: 80011 Labeled in part: '':PATIENT BREATHING CIRCUIT =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1-PATIENT HOSE 22mmIDx42'' 1-PRESSURE GAGE LINE 3/16''IDx54'' 1-PATIENT HOSE 22mmIDx24'' 3-ADAPTERS 22mm x 22mm 1-PATIENT HOSE 22mmIDx6'' 1-ADULT PRESSURE TEE 1-EXHALATION VALVE w/HOLDING ARM& 1-TEMPERATURE ADAPTER 22mmID x 22mm COLLECTION HEAD 2-CUFF 1/4''ID x 5/4'' 1-EXHALATION VALVE LINE 1/8''IDx52''
FDA Recall Z-0423-05 · Posted 2005-01-29
Recalling FirmBio-Med Devices, Inc.
Recall StatusTerminated
Product CodeCBK
Date Initiated2004-12-06
Date Terminated2005-11-21
Product Quantity159 cs
Reason for Recall
Adapters may be occluded potentially preventing inhalation
Firm 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
Root Cause
Other
Distribution Pattern
Nationwide Forign: Canada, Greece, Japna, Israel, Saudi Arabia,
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.