LUCAS Chest Compression System demonstration units recalled
Jolife AB is recalling LUCAS 2, 3, and 3.1 chest compression system demonstration units that may have been provided to customers for clinical use instead of demonstration purposes only.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is that demonstration units may have been used clinically, representing a potential compliance and device-labeling issue rather than an immediate safety threat with documented harm.
Plain-English summary
Jolife AB is recalling demonstration units of the LUCAS 2, 3, and 3.1 chest compression systems. These devices are used for performing external cardiac compressions on adult patients with acute circulatory arrest. The recall was initiated because demonstration units may potentially have been utilized for clinical use.
The recall involves 5 units distributed nationwide in Indiana, Michigan, Ohio, and Texas. Affected units include: LUCAS 2 (Catalog Number 99576-000025, Serial Number 30090111); LUCAS 3 (Catalog Number 21331-000081, Serial Numbers 35172335 and 35160570); and LUCAS 3.1 (Catalog Number 94576-000005, Serial Numbers 3518A164 and 3518D104, which has been scrapped).
Customers who received these demonstration units should verify their intended use. Demonstration units should not be used for clinical purposes.
The recalled product
- 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.
- Manufacturer
- Jolife AB
- Affected units
- 5
Distribution
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