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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-0424-05
Recall Event ID 30580
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
ProductBio Med Devices Patient Breathing Circuit Catalog Number: 80015 Labeled in part: DO NOT REUSE DISPOSABLE DISPOSABLE PATIENT BREATHING CIRCUIT =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1-PATIENT SMOOTH BORE HOSE 1-ADAPTER 22mmx22mm 22mmIDx72'' w/CLIPS 1-ADULT PRESSURE TEE w/.140 HOLE 1-LINE 1/8''IDx84'' 1-TEE 1/8''x1/8''x1/8'' 1-LINE 1/8''IDx24'' 1-HOLDING ARM 1-LINE 1/8''IDx2'' 1-CUFF 1/4''IDx2''
Code Information Lot Numbers: Last 6 digits 09092304, 09092404, 05092704, 02092804 01092904, 05093004, 01100104, 01100404, 01100504, 01101104, 01101204, 01101404 01101804, 01102004, 01102104, 01102504 01102604, 09102704, 09102804, 09110104 09110204, 09110404, 05110804, 09111104 09111504, 01111604, 09111704, 09111804 02111904, 09112204, 09112304, 09112404 05112904, 09113004, 02120104, 09120204  
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 Commerce159 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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