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U.S. Department of Health and Human Services

Class 1 Device Recall BioMed Devices

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  Class 1 Device Recall BioMed Devices see related information
Date Initiated by Firm December 06, 2004
Date Posted January 29, 2005
Recall Status1 Terminated 3 on November 21, 2005
Recall Number Z-0429-05
Recall Event ID 30580
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
Product Bio-Med Patient Breathing Circuit
Product NUmber: 3030-5
Labeled in part:
ONE SET - SINGLE USE CATALOG NO. 3030-5
PATIENT BREATHING CIRCUIT
=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=
CONTENTS:
1-PATIENT HOSE 22mmIDx60''
1-PRESSURE GAGE LINE 1/8''IDx72''
1-PATIENT HOSE 22mmIDx6''
1-EXHALATION VALVE w/COLLECTION HEAD
1-ADULT PRESSURE TEE w/CUFF
1-EXHALATION VALVE LINE 1/8''IDx72
2-ADAPTERS 22mmx22mm
Code Information Lot Number:  09111704
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 2 cs
Distribution Nationwide Forign: Canada, Greece, Japna, Israel, Saudi Arabia,
Total Product Life Cycle TPLC Device Report
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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