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/ 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 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
|
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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.
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