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Terminated

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

FDA Recall Z-0428-05 · Posted 2005-01-29

Recalling FirmBio-Med Devices, Inc.
Recall StatusTerminated
Product CodeCBK
Date Initiated2004-12-06
Date Terminated2005-11-21
Product Quantity107 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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