Z-1021-05

EMCEE OBTURATOR (7F) for use with 8F Sheath, REF #92580008, packaged in individual labeled pouches, 10 units...

Name: Z-1021-05 EMCEE OBTURATOR (7F) for use with 8F Sheath, REF #92580008, packaged in individual labeled pouches, 10 units...
Creator: Boston Scientific Corp
Published: 2004-06-24
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2004-06-24 / Terminated / root cause: labeling and UDI

FDA source

Boston Scientific Corp began a recall of 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... on 2004-06-24. The reason FDA records is "Product labeled to contain Emcee Obturators contained Emcee Dilators". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1021-05
Status: Terminated
Initiated: 2004-06-24
Posted: 2005-07-20
Terminated: 2005-07-21
Recalling firm: Boston Scientific Corporation
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
Product code: DYB Introducer, Catheter
Reason for recall: Product labeled to contain Emcee Obturators contained Emcee Dilators.
Root cause tag: labeling and UDI
FDA 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 in commerce: 90 units
Distribution: Domestic: Two consignees in NJ and IN. Foreign: One consignee in Belgium.
Product codes and lots: 884421 exp 05/2006; 885027 exp 05/2006; 937757 exp. 01/2007.

Product code DYB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)