FastCath Transseptal Catheter Introducers with Hemostasis Valve, DAIG division of St. Jude Medical, Minnetonka, MN, consists of a radiopaque sheath and dilator; Product # 406850.
This recall has been terminated (originally issued March 1, 2007).
- Company
- St. Jude Medical Daig Division
- Recall Initiated
- October 5, 2006
- Posted
- March 1, 2007
- Terminated
- May 25, 2007
- Recall Number
- Z-0535-2007
- Quantity
- 40 Units
- Firm Location
- Minnetonka, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Limited number of FastCath Transseptal Catheter Introducers (REF #406850) are susceptible to the irrigation extension tube on the side port becoming disconnected when a pull force is applied.
Distribution
Nationwide.
Lot / Code Info
Lot number 1239904
Root Cause
Other
Action Taken
The affected customers were notified on 10/5/06 by letter.
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