Class 1 Device Recall BioMed Devices

• Date Initiated by Firm: December 06, 2004
• Date Posted: January 29, 2005
• Recall Status: Terminated on November 21, 2005
• Recall Number: Z-0430-05
• Recall Event ID: 30580
• Product Classification: Ventilator, Continuous, Facility Use - Product Code CBK
• Product: Bio-Med Dental Breathing Circuit Product NUmber: DENTL
• Code Information: Lot Number: 09110804
• FEI Number: 3003952420
• 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: 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: 4 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.