FDAFDA · Food and drugs·Recall number Z-0799-2017
OSCOR ADELANTE BREEZWAY 8F STRAIGHT S79CM D84CM Catalog # AB081211 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Published December 28, 2016 · Recall initiated: October 5, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Oscor, Inc.
- Distributor
- Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM
- Lot
- Lot #'s: C1-08988 Exp. June 1, 2017, C1-08988 Exp. June 1, 2017, OR-04708 Exp. August 19, 2018, C1-08988 Exp. June 1, 2017, C1-08988 Exp. June 1, 2017, C1-09373 Exp. November 5, 2017, C1-09373 Exp. November 5, 2017, OR-04708 Exp. August 19, 2018, and C1-11734 Exp. October 5, 2018
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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