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.
This recall has been terminated (originally issued April 24, 2008).
- Company
- Respironics, Inc.
- Recall Initiated
- October 15, 2007
- Posted
- April 24, 2008
- Terminated
- September 1, 2009
- Recall Number
- Z-1069-2008
- Quantity
- 20950 units
- Firm Location
- Murrysville, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Foreign material: Glass fragments may present in the plastic bag material used to ship components.
Distribution
The products were shipped nationwide to medical facilities.
Lot / Code Info
Lot Numbers 071010, 071011, and 071012.
Root Cause
Environmental control
Action Taken
The recalling firm issued a Recall Notification dated 10/18/07 to its customers. Replacement products were to be sent.
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