Sprinter Cart infusion poles do not meet IEC 60601-1 labeling requirements
Sprinter Cart and Sprinter Cart XL Infusion Poles are being recalled because the device does not comply with the labeling requirements of international standard IEC 60601-1. 7,754 units affected.
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 for non-compliance with a labeling standard, with no device defect or clinical consequence stated.
Plain-English summary
The Sprinter Cart and Sprinter Cart XL Infusion Pole, a component used to hold two 2 kg infusion bags, model number 701033599, UDI 4037691257860, is being recalled. The action covers 7,754 units.
The stated reason is that the device does not comply with the labeling requirements of international standard IEC 60601-1. The FDA classified the action as Class II. The source does not describe a device defect or resulting clinical consequence.
Distribution was worldwide, including nationwide in the United States and to Australia and New Zealand among other markets. The poles are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the model number and UDI above and follow the instructions issued by the manufacturer.
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-noncompliance
- iec-60601-1
- class-ii
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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