LivaNova Recalls Six Sorin Heater-Cooler Systems Due to Bacteria
LivaNova USA Inc. is recalling six Sorin Heater-Cooler System 3T units because post-cleaning water samples tested positive for nontuberculous mycobacteria.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk pathogen (nontuberculous mycobacteria) in a medical device, but the source text does not report any illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
LivaNova USA Inc. is recalling six units of the SORIN Heater-Cooler System 3T (REF 16-02-85). The recall is being conducted because post-deep cleaning water samples from these specific units tested positive for nontuberculous mycobacteria (NTM). The devices are intended for use with Stockert/Sorin S3/S5/C5 heart-lung machines or other heart-lung machines featuring separate temperature control for extracorporeal perfusion of up to 6 hours.
The affected units have serial numbers 16S13187, 16S14887, 16S15335, 16S15336, 16S15337, and 16S11877. These devices were distributed in the United States to the states of Indiana, Missouri, and Ohio. The recall is classified as Class II by the FDA.
Healthcare facilities should contact LivaNova USA Inc. for instructions on how to handle the affected devices. The source text does not specify a consumer action for the general public, as these are specialized medical devices used in clinical settings.
The recalled product
- 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.
- Manufacturer
- LivaNova USA Inc.
- Affected units
- 6
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Serial numbers 16S13187
- 16S14887
- 16S15335
- 16S15336
- 16S15337
- and 16S11877.
Distribution
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