Sprinter Cart/Sprinter Cart XL Infusion Pole. Component recall: Labeling Error
Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.
Why was Sprinter Cart/Sprinter Cart XL Infusion Pole. Component recalled?
Device does not comply with the labeling requirements of international standard IEC 60601-1.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model No. 701033599; UDI: 4037691257860.
- Product
- Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.
- Recalling firm
- Maquet Cardiopulmonary Gmbh
- Quantity
- 7,754 units
- 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, Turkey, Reunion, Romania, Russian Federation, Switzerland, Ukraine, United Kingdom, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Mexico, Paraguay, Peru, Uruguay, Bahrain, Egypt, Iran, Iraq, Jordan, Kuwait, Lebanon, Oman, Pakistan, Qatar, Saudi Arabia, South Africa, United Arab Emirates, Yemen.
- Recall date
- August 6, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)