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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-0423-05
Recall Event ID 30580
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
Product Bio Med Devices Patient Breathing Circuit
Catalog Number: 80011
Labeled in part: '':PATIENT BREATHING CIRCUIT
=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1-PATIENT HOSE 22mmIDx42'' 1-PRESSURE GAGE LINE 3/16''IDx54''
1-PATIENT HOSE 22mmIDx24'' 3-ADAPTERS 22mm x 22mm
1-PATIENT HOSE 22mmIDx6'' 1-ADULT PRESSURE TEE
1-EXHALATION VALVE w/HOLDING ARM&
1-TEMPERATURE ADAPTER 22mmID x 22mm
COLLECTION HEAD 2-CUFF 1/4''ID x 5/4''
1-EXHALATION VALVE LINE 1/8''IDx52''
Code Information Lot Numbers: Last 6 digits  01092304, 01092404, 01092804, 01092904, 01093004, 01100504, 01100604, 01100704 01100804, 01101104, 01101204, 01101404 01101504, 02101804, 01101904, 01102004 01102104, 01102204, 01102504, 05102504 01102604, 01102804, 01102904, 01110104 01110204, 01110504, 09111004, 01111104 05111204, 09111604, 01111704, 01111904 01112204, 09112404, 09113004, 09120204 
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 159 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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