Open, Classified

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

FDA Recall Z-2193-2025 · Posted 2025-07-29

Recalling FirmMaquet Cardiopulmonary Gmbh

Recall StatusOpen, Classified

Product CodeKRI

Date Initiated2025-06-27

Product Quantity7,754 units

Reason for Recall

Device does not comply with the labeling requirements of international standard IEC 60601-1.

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].

Root Cause

Under Investigation by firm

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.