Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.
Summary
The FDA issued a Class II for Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg in by Maquet Cardiopulmonary Gmbh. Reason: Device does not comply with the labeling requirements of international standard IEC 60601-1..
Details
Source
Device Recall
External ID
Z-2193-2025
Action Date
2025-08-06
Status
Ongoing
Category
device
Product Description
Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.
Lot/Code Info: Model No. 701033599; UDI: 4037691257860.
Quantity Affected: 7,754 units
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, 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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-27
Company
Rastatt
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 157 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Maquet Cardiopulmonary Gmbh has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Maquet Cardiopulmonary Gmbh) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Maquet Cardiopulmonary Gmbh have FDA actions?
Maquet Cardiopulmonary Gmbh has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2193-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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