Fabius Trio Gas machine, anesthesia or analgesia. Catalog number 8606000. The product is used in operating rooms and ER, for patient intubation.
This recall has been terminated (originally issued September 23, 2008).
- Company
- Draeger Medical, Inc.
- Recall Initiated
- July 7, 2008
- Posted
- September 23, 2008
- Terminated
- March 8, 2010
- Recall Number
- Z-2338-2008
- Quantity
- 111 units
- Firm Location
- Telford, PA
- Official Source
- View on FDA website ↗
Reason for Recall
The parent company became aware of instances where the lower side rail of the frame of the machine broke inwards when being moved across a threshold; resulting in the machine being unstable.
Distribution
Nationwide
Lot / Code Info
Serial numbers: ARYA-xxxx, ARYB-xxxx, ARYC-xxxx, ARYD-xxxx, ARYE-xxxx, ARYF-xxxx, ARYH-xxxx, ARYJ-xxxx, ARYK-xxxx, ARYL-xxxx, ARYM-xxxx,ARYN-xxxx, ARZA-xxxx ARZB-xxxx (where xxxx represents any 4 digit number)
Root Cause
Process control
Action Taken
The firm has issued a MEDICAL DEVICE RECALL letter dated 7/7/08 to its customers via certified mail. The letter informs them of the problem and to exercise care when using the device until it has been retrofitted. Contact Drager Medical at 1-800-543-5047, #4 for assistance.