Recall Z-2193-2025— Maquet Cardiopulmonary Gmbh
Class II · Ongoing
Class II FDA medical device recall by Maquet Cardiopulmonary Gmbh, initiated 2025-06-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.. Reason: Device does not comply with the labeling requirements of international standard IEC 60601-1..
- Recalling firm
- Maquet Cardiopulmonary Gmbh
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-06-27
- Firm location
- Rastatt, Germany
Product description
Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.
Reason for recall
Device does not comply with the labeling requirements of international standard IEC 60601-1.
Data sourced from openFDA. This site is unofficial and independent of the FDA.