Class 2 Device Recall

• Date Initiated by Firm: December 20, 2005
• Date Posted: March 29, 2006
• Recall Status: Terminated on April 19, 2012
• Recall Number: Z-0697-06
• Recall Event ID: 34248
• 510(K)Number: K983112
• Product Classification: Humidifier, Respiratory Gas, (Direct Patient Interface) - Product Code BTT
• Product: Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT211
• Code Information: Affected lots for all catalogue numbers: 041101-050331(inclusive).
• Recalling Firm/ Manufacturer: Fisher & Paykel Healthcare Inc; 22982 Alcalde Drive 101; Laguna Hills CA 92653
• For Additional Information Contact: Richard Cookson; 949-470-3900
• Manufacturer Reason for Recall: Risk of fire. The manufacturing process may have the potential to damage the insulation of the heater wire in circuits within the specified lot range. This may lead to a potential risk of fire.
• FDA Determined Cause: Other
• Action: On December 20th, 2005 the firm sent the notification letter instructing consignees to check and destroy any stock in the affected lot range. A fax-back Device Recall Response Form was included with the letter and will be used for the company''s effectiveness checks.
• Quantity in Commerce: 341boxes (3,410 pcs)
• Distribution: Nationwide in AR, CA, FL, IL, LA, MN, NC, OH, SD, TX, UT, & VA. International distribution
• 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.

• 510(K) Database: 510(K)s with Product Code = BTT