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

FDA device recall Z-2193-2025 · posted 2025-07-29 · Open, Classified

Recall details

Recalling firm

Maquet Cardiopulmonary Gmbh

Reason for recall

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

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

KRI

Quantity affected

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, Croat

Date initiated

2025-06-27

Date posted

2025-07-29

Location

Rastatt, Germany