Z-2193-2025Class II

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

Name: Z-2193-2025 Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags
Creator: Maquet Cardiopulmonary Gmbh
Published: 2025-06-27
License: https://open.fda.gov/license/

MAQUET CARDIOPULMONARY GmbH / initiated 2025-06-27 / Open, Classified / root cause: labeling and UDI

FDA source

Maquet Cardiopulmonary Gmbh began a recall of Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags on 2025-06-27. FDA classified it as Class II and gives the reason as "Device does not comply with the labeling requirements of international standard IEC 60601-1". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2193-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-27
Posted: 2025-07-29
Recalling firm: MAQUET CARDIOPULMONARY GmbH
Product: Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.
Product code: KRI Accessory Equipment, Cardiopulmonary Bypass
Reason for recall: Device does not comply with the labeling requirements of international standard IEC 60601-1.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: An URGENT MEDICAL DEVICE CORRECTION NOTICE dated June 2025 was mailed to consignees. The notification informs consignees that Getinge will be sending a field service technician to visit and verify if a safety sign is present on affected devices. Consignees are asked to share the recall notification with users of affected devices or to facilities to which product was further distributed for their awareness. Consignees are to complete and return the provided response form to [email protected]. Consignees with any questions are to direct them to Technical Support at 1-877-943-8872 (options 4, 2, 1) or by email at [email protected].
Quantity in commerce: 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.
Product codes and lots: Model No. 701033599; UDI: 4037691257860.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2193-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2193-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-06	2025-07-29

Product code KRI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)