Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall BioMed Devices

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  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-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
=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=
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
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.
-
-