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Maquet Cardiopulmonary Gmbh recalls Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.
Recalled August 6, 2025 · FDA recall Z-2193-2025 · Maquet Cardiopulmonary
Hazard
Device does not comply with the labeling requirements of international standard IEC 60601-1. · FDA Class II
Units
7,754 units
Sold at
Worldwide distribution - US Nationwide and the countries of Australia, New Zealand, Canada, Hong Kong, India, Israel, Japan, Singapore, South Korea, Taiwan, Thailand, Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Serbia, Slovakia, Slovenia, Spain, Sweden, Turkey, Reunion, Romania, Russian Federation, Switzerland, Ukraine, United Kingdom, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Mexico, Paraguay, Peru, Uruguay, Bahrain, Egypt, Iran, Iraq, Jordan, Kuwait, Lebanon, Oman, Pakistan, Qatar, Saudi Arabia, South Africa, United Arab Emirates, Yemen.
Description
Device does not comply with the labeling requirements of international standard IEC 60601-1.
Product
Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.
Manufacturer(s)
Maquet Cardiopulmonary Gmbh
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →