FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-1021-05
- Recalling firm
- Boston Scientific Corp
- Product
- 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
- Status
- Terminated
- Initiated
- 2004-06-24
- Posted
- 2005-07-20
- Terminated
- 2005-07-21
- 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.
- Lot, serial or model codes
- 884421 exp 05/2006; 885027 exp 05/2006; 937757 exp. 01/2007.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 3017892510
- Firm city
- Glens Falls
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28