Maquet Cardiopulmonary Gmbh recalls Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion…

Device does not comply with the labeling requirements of international standard IEC 60601-1.

An URGENT MEDICAL DEVICE CORRECTION NOTICE dated June 2025 was mailed to consignees. The notification informs consignees that Getinge will be sending a field service technician to visit and verify if a safety sign is present on affected devices. Consignees are asked to share the recall notification with users of affected devices or to facilities to which product was further distributed for their awareness. Consignees are to complete and return the provided response form to recallresponses.qrc@getinge.com. Consignees with any questions are to direct them to Technical Support at 1-877-943-8872 (options 4, 2, 1) or by email at techsupport.us@getinge.com.

• FDA enforcement recordOfficial FDA database entry for Z-2193-2025
• FDA device classification · KRIOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.4200The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Maquet Cardiopulmonary GmbhSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.