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

Hazard

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

Details from the source

Reason for recall: Device does not comply with the labeling requirements of international standard IEC 60601-1. Distribution: 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, Quantity: 7,754 units Lot/code info: Model No. 701033599; UDI: 4037691257860.

UPC codes

4037691257860

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.