Reported Dec 28, 2016 · Terminated

OSCOR ADELANTE BREEZEWAY 8F C55¿ S61CM D66CM Catalog # AB081040 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¿ S61CM D66CM Catalog # AB081040 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: C1-09714 Exp. February 11
2018
OR-04657 Exp. April 20
2018
C1-10900 Exp. July 19
2018
C1-10899 Exp. July 19
2018
C1-11048 Exp. August 3
2018
C1-11729 Exp. October 4
2018
C1-11729 Exp. October 4
2018
OR-04729 Exp. October 29
2018
C1-12233 Exp. December 21
2018
C1-12234 Exp. December 22
2018
C1-12234 Exp. December 22
2018
C1-09062 Exp. June 24
2017
C1-09062 Exp. June 24
2017
C1-11047 Exp. August 3
2018 and C1-12234 Exp. December 22
2018 2
Amount recalled: 156

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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