Boston Scientific Impulse Flextrusion Shaft 5F FR4 16391-02 H74916391022, (5-Pack Carton Label), Angiographic Catheters. Made in Mexico Parque Industrial La Mesa Edificio G1, Suites B, H Tijuana, Baja California 22650 MEX Boston Scientific Impulse Flextrusion Shaft 5F FR4 16391-02 H74916391021, (Single Pack Carton/Pouch Label), Angiographic Catheters. Made in Mexico Parque Industrial La Mesa Edificio G1, Suites B, H Tijuana, Baja California 22650 MEX
- Recall Initiated
- June 4, 2007
- Posted
- August 9, 2007
- Terminated
- December 19, 2007
- Recall Number
- Z-1159-2007
- Quantity
- 235
- Firm Location
- Scientific Place Natick, MA
Reason for Recall
Labels on the carton from two batches/lots of Impulse Angiographic Catheters may indicate a different curve style than the device that is actually in the carton.
Distribution
Worldwide, including USA, Austria, Australia, Belgium, Chile, Germany, Spain, Finland, France, Great Britain, Greece, Ireland, Panama, Poland, Sweden, Thailand, and South Africa.
Lot / Code Info
688254
Root Cause
Process control
Action Taken
Sales Force were contacted of the product and problem via voice mail and a memo dated June 4, 2007. Customers were contacted via a letter on June 4, 2007.
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