Z-0130-2009

Oscor Adelante Luer-Lock Peel Away Introducer Set, for introduction of diagnostic or therapeutic devices into...

Name: Z-0130-2009 Oscor Adelante Luer-Lock Peel Away Introducer Set, for introduction of diagnostic or therapeutic devices into...
Creator: Oscor, Inc.
Published: 2008-07-03
License: https://open.fda.gov/license/

Oscor Inc. / initiated 2008-07-03 / Terminated / root cause: manufacturing process

FDA source

Oscor, Inc. began a recall of Oscor Adelante Luer-Lock Peel Away Introducer Set, for introduction of diagnostic or therapeutic devices into the body on 2008-07-03. The reason FDA records is "Difficulty breaking the sheath hub and subsequently to peel the sheath off for Introducer Set, Adelante size 7F". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0130-2009
Status: Terminated
Initiated: 2008-07-03
Posted: 2008-10-29
Terminated: 2008-12-09
Recalling firm: Oscor Inc.
Product: Oscor Adelante Luer-Lock Peel Away Introducer Set, for introduction of diagnostic or therapeutic devices into the body.
Product code: DYB Introducer, Catheter
Reason for recall: Difficulty breaking the sheath hub and subsequently to peel the sheath off for Introducer Set, Adelante size 7F.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Oscor notified the Direct Account by letter on 07/03/2008. Direct account was asked to return all unused Introducers back to Oscor. All returned products should be labeled with the Return Goods Product number.
Quantity in commerce: 396
Distribution: Product was distributed to one direct account in MN.
Product codes and lots: Lot Numbers: C1-02452, C1-02453, C1-02452, C1-02458, C1-02462.

Product code DYB

K073100Class IIIntroducer Sets, Models Adelante and Adelante-SOscor, Inc. / cleared 2007-11-30

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)