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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 Devicessee related information
Date Initiated by FirmDecember 06, 2004
Date PostedJanuary 29, 2005
Recall Status1 Terminated 3 on November 21, 2005
Recall NumberZ-0427-05
Recall Event ID 30580
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
ProductBio Med Devices Patient Breathing Circuit Catalog Number: 8002A-9 Labeled in part: ONE SET - SINGLE USE CATALOG NO. 8002A-9 PATIENT BREATHING CIRCUIT =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1-PATIENT HOSE 22mmIDx60'' 1-EXHALATION VALVE LINE 1/8''IDx108'' 1-PATIENT HOSE 22mmIDx36'' 1-PATIENT HOSE 22mmIDx6'' 1-PRESSURE GAGE LINE 1-EXHALATION VALVE w/HOLDING ARM&COLLECTION HEAD 102'' w/CUFF 1/4''ID 1-ADULT PRESSURE TEE w/CUFF 3-ADAPTERS 22mmx22mm
Code Information Lot Numbers: 05092404, 01100404, 05100604, 05100704 05100804, 05101304, 05101404, 05101504 05101904, 05102204, 05102804, 05110404 02110504, 05110804, 01110904, 05111204 05111504, 01111804, 05112204, 09120104  
FEI Number 3003952420
Recalling Firm/
Manufacturer		 Bio-Med Devices, Inc.
1445 Boston Post Road
Guilford CT 06437-4338
For Additional Information ContactKen Close
203-458-0202
Manufacturer Reason
for Recall		Adapters may be occluded potentially preventing inhalation
FDA Determined
Cause 2		Other
ActionBio-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 Commerce111 cs
DistributionNationwide Forign: Canada, Greece, Japna, Israel, Saudi Arabia,
Total Product Life CycleTPLC 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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