Medtronic Perfusion Systems recalls Medtronic EOPA Arterial Cannula, Model # 77620. Lot: 2015060544 intended to deliver oxygenated blood to the heart durin…
- Recall date
- July 24, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2420-2015
- FDA classification
- Class II
- Brand / firm
- Medtronic Perfusion Systems
- Sold / distributed
- Worldwide distribution. US nationwide including: FL, GA, IL, MI, NY, NC, PA, WV; Germany, Hong Kong, and Italy.
Why it was recalled
EOPA Arterial Cannula Devices in this lot were shipped without the guidewire.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Medtronic EOPA Arterial Cannula, Model # 77620. Lot: 2015060544 intended to deliver oxygenated blood to the heart during cardiopulmonary bypass procedures for up to 6 hours in duration.
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