LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performing external cardiac compressions on adult
Summary
The FDA issued a Class II for LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performin by Jolife AB. Reason: Due to demonstration units of chest compression system being provided to a customer which may potentially be utilized for clinical use..
Details
Source
Device Recall
External ID
Z-1998-2025
Action Date
2025-07-02
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: 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)
Quantity Affected: 5 units
Reason for Recall
Due to demonstration units of chest compression system being provided to a customer which may potentially be utilized for clinical use.
Distribution
U.S. Nationwide distribution in the states of IN, MI, OH and TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-21
Company
Lund
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 160 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Jolife AB has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Jolife AB) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Jolife AB have FDA actions?
Jolife AB has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1998-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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