Z-1998-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 2, 2025
- Initiation Date
- May 21, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 units
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.
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 Pattern
U.S. Nationwide distribution in the states of IN, MI, OH and TX.
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)