Neuroform 3 Microdelivery Stent System, Model Number M003E3400300, Catalog model number and product upn number M00490310
FDA device recall Z-2052-2009 · posted 2009-09-09 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- 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.
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- NJE
- Quantity affected
- 8 units
- Distribution
- International Distribution Only -- Countries of Germany, Great Britain, France, Ireland, and Italy.
- Date initiated
- 2009-05-08
- Date posted
- 2009-09-09
- Date terminated
- 2009-10-21
- Location
- Fremont, CA
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