Neuroform 3 Microdelivery Stent System, Model Number M003E3400300, Catalog model number and product upn number M00490310, manufactured by Boston Scientific Corporation, Fremont, CA.
This recall has been terminated (originally issued September 9, 2009).
- 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
- Official Source
- View on FDA website ↗
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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