FDAFDA · Food and drugs·Recall number Z-0808-2017
OSCOR ADELANTE BREEZWAY 10F STRAIGHT S79CM D84CM Catalog # AB101219 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: C1-11932 Exp. October 28, 2018, C1-08935 Exp. May 14, 2017, C1-11932 Exp. October 28, 2018, C1-12448 Exp. April 14, 2019, and C1-12448 Exp. April 14, 2019
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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