Non-continuous ventilator accessories under the following brand names: a) REMStar (Tower) Ultrafine Qty 1 model number 1036915, b) REMStar Auto M. w/Humid. w/Smartcard. US model number DS500HS; c) REMStar Auto M. w/Smartcard A FLEX US model number DS510S; d) REMStar Auto M. w/Smartcard, CNDA model number CA501S; e) REMStar Auto M w/Smartcard Intl model number IN501S; f) REMStar Auto M w/Smartcard US model number DS500S; g) REMStar Auto w/C-FLEX CANADA model number CA1017454; and h) REMStar Auto w/C-FLEX Domestic Core Pkg model number 1017476. 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-1065-2008
- 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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