Medical device recalls Moderate risk

Maquet Cardiovascular Us Sales, Llc recalls QUADROX-i oxygenators Custom tubing packs for the oxygenator

Recall date
February 23, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1371-2016
FDA classification
Class II
Brand / firm
Maquet Cardiovascular Us Sales, Llc
Sold / distributed
US Nationwide Distribution.

Why it was recalled

Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

QUADROX-i oxygenators Custom tubing packs for the oxygenator

Get recall alerts

Free email alert whenever Maquet Cardiovascular Us Sales, Llc has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Maquet Cardiovascular Us Sales, Llc