LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performing external cardiac compressions on adult pa
FDA device recall Z-1998-2025 · posted 2025-06-20 · Open, Classified
Recall details
- Recalling firm
- Jolife AB
- Reason for recall
- Due to demonstration units of chest compression system being provided to a customer which may potentially be utilized for clinical use.
- Action taken
- 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.
- Root cause
- Employee error
- Status
- Open, Classified
- Product code
- DRM
- Quantity affected
- 5 units
- Distribution
- U.S. Nationwide distribution in the states of IN, MI, OH and TX.
- Date initiated
- 2025-05-21
- Date posted
- 2025-06-20
- Location
- Lund, Sweden
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LUCAS 3 Chest Compression System (K161768) | Jolife AB | 2016-11-09 |
| LUCAS 2 (K090422) | Jolife AB | 2009-06-17 |