RecallDepth

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

Company
Boston Scientific Corp
Recall Initiated
June 24, 2004
Posted
July 20, 2005
Terminated
July 21, 2005
Recall Number
Z-1021-05
Quantity
90 units
Firm Location
Tech Park Glens Falls, NY

Reason for Recall

Product labeled to contain Emcee Obturators contained Emcee Dilators.

Distribution

Domestic: Two consignees in NJ and IN. Foreign: One consignee in Belgium.

Lot / Code Info

884421 exp 05/2006; 885027 exp 05/2006; 937757 exp. 01/2007.

Root Cause

Other

Action Taken

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.

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