LivaNova USA Inc. recalls SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or a…
- Recall date
- September 14, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1099-2019
- FDA classification
- Class II
- Brand / firm
- LivaNova USA Inc.
- Sold / distributed
- US Distribution to states of: IN, MO, and OH.
Why it was recalled
For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
Get recall alerts
Free email alert whenever LivaNova USA Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: LivaNova USA Inc.