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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-0426-05 |
Recall Event ID |
30580 |
Product Classification |
Ventilator, Continuous, Facility Use - Product Code CBK
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Product |
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
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Code Information |
Lot Numbers: 05092304, 01092804, 01100104, 05100504 01100604, 05100704, 05101204, 01101304 05102104, 01102504, 01102604, 09102704 09102804, 09110404, 01110404, 09110504 09110904, 02111004, 09111104, 09111204 09111504, 09112304, 09112904, 09113004 09120104 |
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 |
71 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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