Carina Home Ventilator. The device is used as a continuous respirator/ventilator for home use.
This recall has been terminated (originally issued May 14, 2009).
- Company
- Draeger Medical, Inc.
- Recall Initiated
- January 21, 2009
- Posted
- May 14, 2009
- Terminated
- January 5, 2010
- Recall Number
- Z-1263-2009
- Quantity
- 40 units
- Firm Location
- Telford, PA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide Distribution -- states of CA, FL, GA, HI, IL, LA, MA, MN, OH, and TX.
Lot / Code Info
Catalog Numbers 5704757 and 5704758.
Root Cause
Software design
Action Taken
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 questions about the notification letter to Drager Medical, Inc. by calling 1-800-543-5047 (press "1" at the prompt and then press "2349#"). Direct questions regarding updating your device when the new software is available, contact Drager Service Technical Support at 1-800-543-5047 (press "4" at the prompt).