Neuroform 3 Microdelivery Stent System, Model Number M003E3400300, Catalog model number and product upn number M00490310, manufactured by Boston Scientific Corporation, Fremont, CA.
- Company
- Boston Scientific Corporation
- Recall Initiated
- May 8, 2009
- Posted
- September 9, 2009
- Terminated
- October 21, 2009
- Recall Number
- Z-2052-2009
- Quantity
- 8 units
- Firm Location
- Fremont, CA
Reason for Recall
Mislabeling-- Product was placed in a carton, which has printed on it the name of another product. A correct product label was placed on the carton.
Distribution
International Distribution Only -- Countries of Germany, Great Britain, France, Ireland, and Italy.
Lot / Code Info
Batch numbers 8048028 and 8048029.
Root Cause
Employee error
Action Taken
The firm issued an Urgent Product Field Action Notice to all listed customers, along with a reply verification form, requesting the return of affected products.
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