Floppy Cronus Endovascular Guidewire, Length 180 cm (partial coat), Diameter 0.014 inch, Part Number 001-001232-3
- Company
- Stereotaxis Inc
- Recall Initiated
- January 27, 2004
- Posted
- July 20, 2004
- Terminated
- October 31, 2005
- Recall Number
- Z-0593-04
- Quantity
- 72 guidewires
- Firm Location
- Saint Louis, MO
Reason for Recall
The magnet at the end of the guidewire could break off.
Distribution
The product was shipped to consignees in Iowa, Massachusetts, Missouri, Oklahoma, and Texas in the United States and to consignees in Germany and The Netherlands.
Lot / Code Info
Lots 0305-4024, 0305-4025, 0305-4026, 0306-4027, 0307-4028, 0307-4030, 0307-4031, and 0307-4050
Root Cause
Other
Action Taken
Consignees were sent a notice dated January 27, 2004. The notice requested that consignees stop using the product and stated that a firm representative would contact the consignees. The firm''s representatives have retrieved all of the product at the consignees.
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