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Terminated

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''

FDA Recall Z-0424-05 · 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.

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