LivaNova Recalls SORIN Heater-Cooler Systems Due to Disinfectant Failure
LivaNova USA Inc. is recalling SORIN Heater-Cooler System 3T units because a chemical reaction may render the water preservative ineffective, potentially allowing micro-organism growth.
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 medical device where the failure of a disinfectant could lead to infection, but the source text does not report any illnesses or injuries, fitting the 'High' criteria for risk-of-harm products without reported injury.
Plain-English summary
LivaNova USA Inc. is recalling the SORIN Heater-Cooler System 3T, a medical device used with heart-lung machines for extracorporeal perfusion. The recall involves 8,671 units distributed worldwide, including the United States and Puerto Rico.
The firm identified that a chemical reaction may render the disinfectant/water preservative used in the device ineffective. This preservative is intended to inhibit or limit the growth of micro-organisms. Additionally, the firm is releasing a design upgrade to reduce the risk of potential emission of aerosols from the device.
Healthcare facilities should stop using the affected units and contact LivaNova USA Inc. for further instructions. The affected serial number ranges are listed in the agency's recall documentation for specific voltage configurations.
The recalled product
- Product
- SORIN Heater-Cooler System 3T 120V~/60Hz REF 16-02-85 Description of product: The St¿ckert Heater-Cooler System is an independent (i.e. independent of the water supply) 3-circuit-heating/cooling system. The three separate water circuits have been developed to serve as: "…
- Manufacturer
- LivaNova USA Inc.
- Affected units
- 8,671
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 (13)
- 16-02-80 Stockert Heater-Cooler System 3T
- 230V
- Serial #s 16S10027 thru 16S16874 16-02-81 Stockert Heater-Cooler System 3T
- 240 v/60 Hz
- Serial #s 16S10743 thru 16S11708 16-02-82 Stockert Heater-Cooler System 3T
- 208 v/60 Hz
- Serial #s 16S10772 thru 16S16840 16-02-83 Stockert Heater-Cooler System 3T
- 127V/60Hz
- Serial #s 16S11455 thru 16S16509 16-02-85 Stockert Heater-Cooler System 3T
- 120 v/60 Hz
- Serial #s 16S10958 thru 16S16847 16-02-95 Stockert Heater-Cooler System 3T
- 200V/50Hz/60Hz
- Serial #s 16S12004 thru 16S16818
Distribution
Distributed nationwide across the United States.
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