Recall Z-1021-05 ยท DYB Introducer, Catheter
Boston Scientific Corp
EMCEE OBTURATOR (7F) for use with 8F Sheath, REF #92580008, packaged in individual labeled pouches, 10 units per box, 40 boxes per case. Firm on label: Schneider/NAMIC, Glens Falls, New York 12801
| Date | Jul 20, 2005 (initiated Jun 24, 2004) |
| Status | Terminated |
| Reason | Product labeled to contain Emcee Obturators contained Emcee Dilators. |
| Root cause | Other |
| Action | Phone calls to one consignee on 6/24/2004 and the 2nd U.S. consignee on 6/30/2004. The foreign consignee was notified via mail on 10/18/2004. |
| Quantity | 90 units |
| Distribution | Domestic: Two consignees in NJ and IN. Foreign: One consignee in Belgium. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.