FDA Medical Device Recalls (openFDA)
Maquet Cardiopulmonary Gmbh: Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.
- Recall number
- Z-2193-2025
- Recalling firm
- Maquet Cardiopulmonary Gmbh
- Product
- Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.
- Status
- Open, Classified
- Initiated
- 2025-06-27
- Posted
- 2025-07-29
- Terminated
- not on file
- Reason
- Device does not comply with the labeling requirements of international standard IEC 60601-1.
- 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 recallresponses.qrc@getinge.com. Consignees with any questions are to direct them to Technical Support at 1-877-943-8872 (options 4, 2, 1) or by email at techsupport.us@getinge.com.
- 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.
- Lot, serial or model codes
- Model No. 701033599; UDI: 4037691257860.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KRI
- Firm FEI
- 3009507273
- Firm city
- Rastatt
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28