Sprinter Cart Infusion Pole recalled for labeling non-compliance
Maquet is recalling 7,754 Sprinter Cart and Sprinter Cart XL Infusion Poles worldwide due to labeling that does not comply with international electrical safety standards (IEC 60601-1). No injuries or illnesses have been reported.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall involving a labeling compliance issue with no reported injuries or illnesses. While the classification indicates moderate regulatory concern, the hazard is documentation-based and theoretical with no documented harm.
Plain-English summary
The Sprinter Cart and Sprinter Cart XL Infusion Poles, manufactured by Maquet Cardiopulmonary Gmbh, are being recalled because their labeling does not comply with the international electrical safety standard IEC 60601-1. The affected devices are used to hold 2 × 2 kg infusion bags in medical settings.
Approximately 7,754 units have been distributed worldwide, including throughout the United States and in countries across Europe, Asia, the Middle East, Africa, and the Americas. The recall affects Model No. 701033599 (UDI: 4037691257860).
No injuries or illnesses related to this issue have been reported. Healthcare facilities using these infusion poles should review device labeling and contact Maquet Cardiopulmonary Gmbh for updated materials or further instructions.
The recalled product
- Product
- Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.
- Manufacturer
- Maquet Cardiopulmonary Gmbh
- Hazard
- labeling-non-compliance
- electrical-safety
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model No. 701033599
- UDI: 4037691257860.
Distribution
Distributed nationwide across the United States.
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