EMCEE OBTURATOR (7F) for use with 8F Sheath, REF #92580008, packaged in individual labeled pouches, 10 units per box, 40
FDA device recall Z-1021-05 · posted 2005-07-20 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corp
- Reason for recall
- Product labeled to contain Emcee Obturators contained Emcee Dilators.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 90 units
- Distribution
- Domestic: Two consignees in NJ and IN. Foreign: One consignee in Belgium.
- Date initiated
- 2004-06-24
- Date posted
- 2005-07-20
- Date terminated
- 2005-07-21
- Location
- Glens Falls, NY
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