| Class 1 Device Recall BioMed Devices | |
Date Initiated by Firm | December 06, 2004 |
Date Posted | January 29, 2005 |
Recall Status1 |
Terminated 3 on November 21, 2005 |
Recall Number | Z-0425-05 |
Recall Event ID |
30580 |
Product Classification |
Ventilator, Continuous, Facility Use - Product Code CBK
|
Product | Bio Med Devices Patient Breathing Circuit
Catalog Number: 8002A
Labeled in part:
ONE SET - SINGLE USE CATALOG NO. 8002A
PATIENT BREATHING CIRCUIT
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CONTENTS:
1-PATIENT HOSE 22mmIDx42''
1-PRESSURE GAGE LINE
1-PATIENT HOSE 22mmIDx6''
1-EXHALATION VALVE w/HOLDING ARM&
COLLECTION HEAD
48'' w/CUFF 1/4''ID
1-ADULT PRESSURE TEE w/CUFF
1-EXHALATION VALVE LINE 1/8''IDx48''
2-ADAPTERS 22mmx22mm |
Code Information |
Lot Numbers: last 6 digits 09092204, 01092404, 05093004, 01100604 05100704, 02100804, 05101204, 01101804 09102804, 01110104, 09110404, 05110404 05110904, 05111104, 09111604, 09111804 09111904, 09112204, 09112404, 05120104 |
Recalling Firm/ Manufacturer |
Bio-Med Devices, Inc. 1445 Boston Post Road Guilford CT 06437-4338
|
For Additional Information Contact | Ken Close 203-458-0202 |
Manufacturer Reason for Recall | Adapters may be occluded potentially preventing inhalation |
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 | 58 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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