Recall Z-2193-2025 ยท KRI Accessory Equipment, Cardiopulmonary Bypass
Maquet Cardiopulmonary Gmbh
Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.
| Date | Jul 29, 2025 (initiated Jun 27, 2025) |
| Status | Open, Classified |
| 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 ( |
| 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, Lith |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.