Recall Z-1065-2008 ยท BZD Ventilator, Non-Continuous (Respirator)
Respironics, Inc.
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
| Date | Apr 24, 2008 (initiated Oct 15, 2007) |
| Status | Terminated |
| Reason | Foreign material: Glass fragments may present in the plastic bag material used to ship components. |
| Root cause | Environmental control |
| Action | The recalling firm issued a Recall Notification dated 10/18/07 to its customers. Replacement products were to be sent. |
| Quantity | 20950 units |
| Distribution | The products were shipped nationwide to medical facilities. |
| FDA record | Open on fda.gov |