Class 2 Device Recall Noncontinuous ventilators

• Date Initiated by Firm: October 15, 2007
• Date Posted: April 24, 2008
• Recall Status: Terminated on September 01, 2009
• Recall Number: Z-1067-2008
• Recall Event ID: 45545
• 510(K)Number: K052110
• Product Classification: ventilation accessories - Product Code BZD
• Product: Non-continuous ventilator accessories under the following brand names: a) REMStar M US model number DS100 and b) REMStar M w/Humid US model number DS100H. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
• Code Information: Lot Numbers 071010, 071011, and 071012.
• Recalling Firm/ Manufacturer: Respironics, Inc.; 1001 Murry Ridge Ln; Murrysville PA 15668-8550
• For Additional Information Contact: Katherine dePadua; 724-387-7770
• Manufacturer Reason for Recall: Foreign material: Glass fragments may present in the plastic bag material used to ship components.
• FDA Determined Cause: Environmental control
• Action: The recalling firm issued a Recall Notification dated 10/18/07 to its customers. Replacement products were to be sent.
• Quantity in Commerce: 20950 units
• Distribution: The products were shipped nationwide to medical facilities.
• 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 = BZD