Howell D.A.S.H. II Access System, Wire Guided Sphincterotome
- Company
- Wilson-Cook Medical Inc
- Recall Initiated
- December 17, 2003
- Posted
- January 7, 2004
- Terminated
- April 16, 2004
- Recall Number
- Z-0301-04
- Quantity
- 18 units
- Firm Location
- Winston Salem, NC
Reason for Recall
Wire-Guided Sphinterotomes may be packaged with an incorrect wire guide label.
Distribution
Units were distributed to medical facilities in AZ, CA, MN, NJ, NY, OH and Egypt.
Lot / Code Info
Reorder Number: DASH-35-480, Lot Number: W1815864
Root Cause
Process control
Action Taken
Consignees were notified by letter sent via Certified Mail on December 17, 2003.
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