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Class 1 Device Recall BioMed Devices |
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Date Initiated by Firm |
December 06, 2004 |
Date Posted |
January 29, 2005 |
Recall Status1 |
Terminated 3 on November 21, 2005 |
Recall Number |
Z-0428-05 |
Recall Event ID |
30580 |
Product Classification |
Ventilator, Continuous, Facility Use - Product Code CBK
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Product |
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
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Code Information |
Lot Numbers: 05092204, 05101104, 05101304, 05101404 05102004, 05102604, 05102804, 05110204 05110304, 05110904, 05111804, 05112404 05120104 |
Recalling Firm/ Manufacturer |
Bio-Med Devices, Inc. 1445 Boston Post Road Guilford CT 06437-4338
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For Additional Information Contact |
Ken Close 203-458-0202
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Manufacturer Reason for Recall |
Adapters may be occluded potentially preventing inhalation
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FDA Determined Cause 2 |
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 |
107 cs |
Distribution |
Nationwide
Forign: Canada, Greece, Japna, Israel, Saudi Arabia, |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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