Neuroform 3 Microdelivery Stent System, Model Number M003E3400300, Catalog model number and product upn number M00490310, manufactured by Boston Scientific Corporation, Fremont, CA.
FDA Recall Z-2052-2009 · Posted 2009-09-09
Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeNJE
Date Initiated2009-05-08
Date Terminated2009-10-21
Product Quantity8 units
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.
Firm Action
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.
Root Cause
Employee error
Distribution Pattern
International Distribution Only -- Countries of Germany, Great Britain, France, Ireland, and Italy.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.