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Terminated

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

FDA Recall Z-1021-05 · Posted 2005-07-20

Recalling FirmBoston Scientific Corp
Recall StatusTerminated
Product CodeDYB
Date Initiated2004-06-24
Date Terminated2005-07-21
Product Quantity90 units

Reason for Recall

Product labeled to contain Emcee Obturators contained Emcee Dilators.

Firm 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.

Root Cause

Other

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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