Sprinter Cart/Sprinter Cart XL Infusion Pole. Component… recallZ-2193-2025 · Maquet Cardiopulmonary Gmbh · initiated Jun 27, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Maquet Cardiopulmonary Gmbh or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Device does not comply with the labeling requirements of international standard IEC 60601-1.
FDA root cause category: Under Investigation by firm
What the company is doing
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].
Recall details
- Recall number
- Z-2193-2025
- Status
- Open, Classified
- Initiated by the company
- Jun 27, 2025
- Posted by the FDA
- Jul 29, 2025
- Recalling firm
- Maquet Cardiopulmonary Gmbh
- Quantity
- 7,754 units
- Product code
- KRI
- 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 description
Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.
Code information (models, lots, serial numbers)
Model No. 701033599; UDI: 4037691257860.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NA INFUSION POLEMaquet Cardiopulmonary AG · ACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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