Reported Dec 28, 2016 · Terminated

OSCOR ADELANTE BREEZEWAY 8F C55¿ S79CM D84CM Catalog # AB081044 Is designed to facilitate the introduction of catheters…

Oscor, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Oscor, Inc. · 3816 Desoto Blvd · Palm Harbor, FL · 34683-1618

OSCOR ADELANTE BREEZEWAY 8F C55¿ S79CM D84CM Catalog # AB081044 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

Lot codes and dates: Lot #'s: C1-12152 Exp. November 30
2018
C1-09518 Exp. December 21
2017
C1-09748 Exp. February 16
2018
C1-09899 Exp. March 12
2018
C1-10040 Exp. April 5
2018
C1-10040 Exp. April 5
2018
C1-10149 Exp. April 23
2018
C1-10330 Exp. May 11
2018
C1-10329 Exp. May 11
2018
C1-10382 Exp. May 17
2018
C1-11571 Exp. September 25
2018
C1-11571 Exp. September 25
2018
and OR-04757 Exp. December 22
2018
Amount recalled: 991

The agency filed one notice per product. You are reading one of them; the other 29 are below.

17 more are in the archive.

Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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