Class 2 Device Recall

• Date Initiated by Firm: December 21, 2004
• Date Posted: February 18, 2005
• Recall Status: Terminated on November 21, 2005
• Recall Number: Z-0553-05
• Recall Event ID: 31046
• 510(K)Number: K020332
• Product Classification: Humidifier, Respiratory Gas, (Direct Patient Interface) - Product Code BTT
• Product: RT130 and RT131 Neonatal/ Infant Breathing Circuits, heated wire. For use with MR850 Respiratory Humidifier.
• Code Information: Lot umbers in the range 040701 to 041216
• FEI Number: 3000210616
• Recalling Firm/ Manufacturer: Fisher & Paykel Healthcare Inc; 22982 Alcalde Drive 101; Laguna Hills CA 92653
• For Additional Information Contact: Richard Cookson; 800-792-3912 Ext. 327
• Manufacturer Reason for Recall: Pressure elbow may be partly occluded.
• FDA Determined Cause: Other
• Action: Recall was initiated on 12/17/2004 at all firm locations and distributors worldwide. The recall letter includes instructions for performing a mitigation until new stock is supplied.
• Quantity in Commerce: 2200
• Distribution: Worldwide
• 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