Recall Z-1099-2019
LivaNova USA Inc. · initiated September 14, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.
Codes / lots: Serial numbers 16S13187, 16S14887, 16S15335, 16S15336, 16S15337, and 16S11877.
Reason for recall
For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).
FDA-determined cause: Material/Component Contamination
Action taken
The recalling firm, LivaLova, contacted the first customer by phone on 9/14/2018 followed by an "IMPORT" letter, the first of which was dated 9/18/2018. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: keep these devices out of service until the investigation is complete. To return your device, please email 3T.US@livanova.com. If taking Serial Numbers 16S15335 and 16S15337 out of service will negatively impact your clinical practice, we can arrange for delivery of loaner devices during this investigation and,as necessary, while they undergo repeat Deep Cleaning Process. If you have any questions, contact V.P., Clinical, Quality, and Regulatory Services at 303-467-6306 or email: joan.ceasar@livanova.com.
Details
- Recall number
- Z-1099-2019
- Initiated
- September 14, 2018
- Terminated
- September 14, 2022
- Product code
- DWC – Controller, Temperature, Cardiopulmonary Bypass
- Quantity
- 6 devices
- Distribution
- US Distribution to states of: IN, MO, and OH.
- Recalling firm
- LivaNova USA Inc., Arvada, CO