Recall Z-1263-2009 ยท CBK Ventilator, Continuous, Facility Use
Draeger Medical, Inc.
Carina Home Ventilator. The device is used as a continuous respirator/ventilator for home use.
| Date | May 14, 2009 (initiated Jan 21, 2009) |
| Status | Terminated |
| Reason | The device may not generate a pilot line disconnect alarm if the pilot line becomes disconnected, which may potentially result in a substantial reduction in tidal volume delivery. |
| Root cause | Software design |
| Action | An "Urgent - Medical Device Recall" Letter dated January 2009 was issued to consignees via certified mail. The letter described the issue, specific conditions, background information, and precautions for customers. An additional letter dated January 22, 2009 was included with the "Urgent - Medical Device Recall" letter which instructed consignees to inform an enduser of the contents of the notification letter because some of the consignees are home care device/service providers. When the new hardware/software solution is available, affected devices will be updated free of charge. Direct qu |
| Quantity | 40 units |
| Distribution | Nationwide Distribution -- states of CA, FL, GA, HI, IL, LA, MA, MN, OH, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060705 | CARINA HOME Draeger Medical B.V., Jun 14, 2006 |