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.
Recall
- Recall Number
- Z-1065-2008
- Event Number
- 45545
- Firm
- Respironics, Inc.
- FEI Number
- 2518422
- Product Code
- BZD
- Status
- Terminated
- Root Cause
- Environmental control
- Initiated
- October 15, 2007
- Posted
- April 24, 2008
- Terminated
- September 1, 2009
- Address
- 1001 Murry Ridge Ln, Murrysville, PA, 15668-8550
Description
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.
Foreign material: Glass fragments may present in the plastic bag material used to ship components.
The recalling firm issued a Recall Notification dated 10/18/07 to its customers. Replacement products were to be sent.
The products were shipped nationwide to medical facilities.
20950 units