FDA-Device2016-04-20Class II
Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator
Maquet Cardiovascular Us Sales, Llc
Hazard
Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.
Sold states
US Nationwide Distribution.
Affected count
72,000 units in total
Manufactured in
45 Barbour Pond Drive, N/A, Wayne, NJ, United States
Products
Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1373-2016Don't want to check this manually?
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