FDA Medical devices recall ·
LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for… recall
- Recall number
- Z-1998-2025
- Date
- (initiated May 21, 2025)
- Company / brand
- Jolife AB
Scheelevagen 17, Lund, Sweden - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 5 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Due to demonstration units of chest compression system being provided to a customer which may potentially be utilized for clinical use.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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)
Distribution
U.S. Nationwide distribution in the states of IN, MI, OH and TX.
States: Indiana Michigan Ohio Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1998-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.