FDA-Device2014-12-31Class II
Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Number BEQ-HMOD-30000 For cardiac surgery in combination with a heart lung machine to oxygenate blood, remove carbon dioxide and adjust blood temperature.
Maquet Cardiovascular Us Sales, Llc
Hazard
Maquet has confirmed through a customer complaint that while the oxygenators and the pouches for a single lot of Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioliine Coating are labeled correctly with the Bioline coating, the individual cartons and 4-pack shipping containers of this lot incorrectly bear Softline coating labels instead of the bioline coating labels.
Sold states
Distributed in DC, MA, & MI.
Affected count
28 units
Manufactured in
45 Barbour Pond Drive, Wayne, NJ, United States
Products
Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Number BEQ-HMOD-30000 For cardiac surgery in combination with a heart lung machine to oxygenate blood, remove carbon dioxide and adjust blood temperature.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0870-2015Don't want to check this manually?
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