Oscor, Inc. Recall: OSCOR ADELANTE BREEZWAY 10F STRAIGHT S79CM D84CM Catalog # AB101219 Is
Oscor, Inc. Recall: OSCOR ADELANTE BREEZWAY 10F STRAIGHT S79CM D84CM Catalog # AB101219 Is is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Oscor, Inc.; Product: OSCOR ADELANTE BREEZWAY 10F STRAIGHT S79CM D84CM Catalog # AB101219 Is designed to facilitate the introduction of catheters t
| Recalling firm | Oscor, Inc. |
|---|---|
| Product | 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. |
| Reason for recall | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | 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 |
| Recall initiated | 20161005 |
| Recall number | Z-0808-2017 |
| Category | device |
| State | FL |
| Country | United States |
$29/mo
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