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
This recall has been terminated (originally issued July 20, 2005).
- 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
- Official Source
- View on FDA website ↗
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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