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U.S. Department of Health and Human Services

Class 2 Device Recall Noncontinuous ventilators

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  Class 2 Device Recall Noncontinuous ventilators see related information
Date Initiated by Firm October 15, 2007
Date Posted April 24, 2008
Recall Status1 Terminated 3 on September 01, 2009
Recall Number Z-1069-2008
Recall Event ID 45545
510(K)Number K021861  K052110  K052110  K052110  
Product Classification ventilation accessories - Product Code BZD
Product Non-continuous ventilator accessories under the following brand names: a) REMStar Pro2 Domestic model number 1020923; b) REMStar Pro M, w/Humid w/Smartcard US model number DS400HS; c) REMStar Pro M w/Smartcard US model number DS400S; d) REMStar Pro/Plus Silencer Cap model number 1005962; e) REMStar Pro/Plus/Auto/Lite Pollen model number 1005964; f) REMStar Pro/Plus/Auto/Lite Pollen SNGL model number 1001389; g) REMStar Pro/Plus/Auto/Lite Ultrafine model number 1005945; and h) REMStar Pro/Plus/Auto/Lite Ultrafine Qty 1 model number 1039607. 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/
Respironics, Inc.
1001 Murry Ridge Ln
Murrysville PA 15668-8550
For Additional Information Contact Katherine dePadua
Manufacturer Reason
for Recall
Foreign material: Glass fragments may present in the plastic bag material used to ship components.
FDA Determined
Cause 2
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 and Original Applicant = RESPIRONICS, INC.