Functional Anaesthetic Discography (F.A.D.) Catheter System, Catalog #: D01A, Kyphon, Inc., Sunnyvale, Ca 94089
This recall has been terminated (originally issued February 5, 2008).
- Company
- Kyphon Inc
- Recall Initiated
- April 25, 2006
- Posted
- February 5, 2008
- Terminated
- June 10, 2008
- Recall Number
- Z-0948-2008
- Quantity
- By Lot Number : J 6013102 = 147, Lot: J6033012 = 23
- Firm Location
- Sunnyvale, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Guidewire Breakages: during the Functional Anaesthetic Discography (F.A.D.) procedure.
Distribution
Nationwide including states of AL, AZ, CA, FL, IN, NH, NY, DC, ME, MD, WI, and PA.
Lot / Code Info
Lot Numbers: J6033012 and J6013102
Root Cause
Labeling design
Action Taken
A customer advisory letter was sent on 4/25/06 to consignees. In some cases some were issued in person. Follow up with field representatives was also conducted. Both contacts involved providing IMPORTANT CHANGES IN INSTRUCTIONS FOR USE that are to be attached to the on site users documents. The recalling firm is updating future distribution with the new instructions for use.
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