LivaNova Recalls Sorin Stockert Heater-Cooler Systems Due to Suspected Microbial Contamination
LivaNova USA is recalling 2,408 Sorin Stockert Heater-Cooler System 3T units because they are suspected of microbial contamination and may contain visible biofilm.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves suspected microbial contamination and visible biofilm in a medical device, which aligns with the rubric criteria for Severe severity involving significant injury or property damage reports or high-risk contamination.
Plain-English summary
LivaNova USA is recalling 2,408 units of the Sorin Stockert Heater-Cooler System 3T. The affected devices include Item # 16-02-81 (240 v/60 Hz), Item # 16-02-82 (208 v/60 Hz), and Item # 16-02-85 (120 v/60 Hz). The recall covers serial numbers ranging from 16S10743 to 6S11708, 16S10772 to 16S16840, and 16S10958 to 16S16847.
The recall was initiated because the devices are suspected of microbial contamination and may contain visible biofilm. The affected units were distributed to facilities in numerous states and territories, including Minnesota, Texas, Washington, Oregon, Illinois, Ohio, South Carolina, Alaska, Pennsylvania, California, Wisconsin, Georgia, New Jersey, Florida, Arizona, Kentucky, Mississippi, Missouri, Louisiana, Arkansas, Massachusetts, Michigan, Montana, Colorado, Tennessee, Nebraska, North Carolina, Virginia, Nevada, Hawaii, Puerto Rico, Wyoming, Alabama, Oklahoma, Indiana, Connecticut, Maine, Iowa, Kansas, New Mexico, South Dakota, and the District of Columbia.
The U.S. Food and Drug Administration has classified this as a Class II recall. LivaNova USA is notifying customers that a Deep-Cleaning Service is now available in the United States for these devices. Healthcare facilities should contact LivaNova USA to arrange for the service.
The recalled product
- Product
- Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #: 16-02-85, 120 v/60 Hz
- Manufacturer
- LivaNova USA
- Affected units
- 2,408
Distribution
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