Maquet Cardiovascular Us Sales, Llc recalls Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO) for the treatment of respiratory insuffici

Recalled February 27, 2013 · FDA recall Z-0839-2013 · Maquet Cardiovascular Us Sales

Hazard

ELS 15 Fr Cannula could potentially contain an occluded arterial lumen. · FDA Class II

Units

41 units - US Distirbution; 216 units - OUS Distribution

Sold at

Worldwide Distribution-USA including the states of AZ, CO, FL, TN, and TX and the countries of Australia, Canada, Czech Republic, Dubai/Bahrain/Kuwait/Lebanon/Saudi Arabia/Yemen, France, Germany, Hong Kong, Italy, Japan, Netherlands, Singapore, South Africa, Sweden, Switzerland, Thailand, Turkey, and UK.

Description

ELS 15 Fr Cannula could potentially contain an occluded arterial lumen.

Product

Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO) for the treatment of respiratory insufficiency in infants.

Manufacturer(s)

Maquet Cardiovascular Us Sales, Llc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →