Recall Z-1998-2025 ยท DRM Compressor, Cardiac, External
Jolife AB
LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.
| Date | Jun 20, 2025 (initiated May 21, 2025) |
| Status | Open, Classified |
| Reason | Due to demonstration units of chest compression system being provided to a customer which may potentially be utilized for clinical use. |
| Root cause | Employee error |
| Action | On 05/21/2025, the firm send via certified mail an "URGENT: MEDICAL DEVICE RECALL" Letter to customers informing them that demonstration LUCAS devices were given to customers for use without the proper labeling. These demonstration units are not maintained in a clinically usable state and are not to be loaned to customers or used in a clinical setting. Customer are instructed to: 1. Immediately check their internal inventory to locate the product listed on the attached business reply form, stop usage, and remove them from their point of use. 2. Return the enclosed business reply form by emai |
| Quantity | 5 units |
| Distribution | U.S. Nationwide distribution in the states of IN, MI, OH and TX. |
| FDA record | Open on fda.gov |