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Terminated

Bio Med Devices Patient Breathing Circuit Catalog Number: 8002A-7 Labeled in part: ONE SET - SINGLE USE ATALOG NO. 8002A-7 PATIENT BREATHING CIRCUIT =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1-PATIENT HOSE 22mmIDx60'' 1-EXHALATION VALVE LINE 1/8''IDx90'' 1-PATIENT HOSE 22mmIDx18'' 1-PATIENT HOSE 22mmIDx6'' 1-PRESSURE GAGE LINE 84'' w/CUFF 1/4''ID 1-EXHALATION VALVE w/HOLDING ARM& COLLECTION HEAD 1-ADULT PRESSURE TEE w/CUFF 3-ADAPTERS 22mmx22mm

FDA Recall Z-0426-05 · Posted 2005-01-29

Recalling FirmBio-Med Devices, Inc.
Recall StatusTerminated
Product CodeCBK
Date Initiated2004-12-06
Date Terminated2005-11-21
Product Quantity71 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.

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