Class 2 Device Recall LUCAS 2, 3 and 3.1

• Date Initiated by Firm: May 21, 2025
• Date Posted: June 20, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1998-2025
• Recall Event ID: 96729
• 510(K)Number: K090422 K161768
• Product Classification: Compressor, cardiac, external - Product Code DRM
• Product: 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.
• Code Information: Lucus 2 Catalog Number: 99576-000025 UDI-DI code: 00883873904565 Serial Number: 30090111 Lucas 3 Catalog Number: 21331-000081 UDI-DI code: 00883873861875 Serial Numbers: 35172335 35160570 Lucas 3.1 Catalog Number: 94576-000005 UDI-DI code: 00883873834329 Serial Numbers: 3518A164 3518D104 (Scrapped)
• FEI Number: 3005445717
• Recalling Firm/ Manufacturer: Jolife AB; Scheelevagen 17; Ideon Science Park; Lund Sweden
• For Additional Information Contact: Joyce Staggs; 425-867-4597
• Manufacturer Reason for Recall: Due to demonstration units of chest compression system being provided to a customer which may potentially be utilized for clinical use.
• FDA Determined 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 email to RSRecall@Stryker.com to confirm receipt of this notification. 3. Upon receipt of the completed business reply form, Stryker will contact customers to arrange for the return and replacement of the affected product(s). 4. Maintain awareness of this communication internally until all required actions have been completed within their facility. Keep this communication close to the affected items until replacement. 5. Inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients appropriately. Any questions or concerns, contact Customer Service +1 800 787 9537, option 2, from 8:00 AM to 7:00 PM (Eastern Time), Monday Friday or by email at medtechsup@stryker.com.
• Quantity in Commerce: 5 units
• Distribution: U.S. Nationwide distribution in the states of IN, MI, OH and TX.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = DRM