Sorin Heater-Cooler Devices Recalled for Potential Microbial Colonization
Sorin Group USA is recalling Stockert Heater-Cooler 3T devices due to the potential for microbial colonization, including Mycobacteria, if proper disinfection and maintenance are not performed.
What this means for you
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 (Mycobacteria) and a medical device where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Sorin Group USA, Inc. is recalling the Sorin Stockert Heater-Cooler 3T, 120 V / 60 Hz, a device used for temperature control during extracorporeal perfusion. The recall involves 1,755 units with serial numbers ranging from 16S10958 to 16S15634. These devices were distributed nationwide in the United States and internationally to numerous countries.
The recall is issued because of the potential colonization of organisms, including Mycobacteria, within the devices. This risk exists if proper disinfection and maintenance are not performed according to the Instructions for Use. The agency has classified this recall as Class II.
Healthcare facilities and users of these devices should contact the recalling firm for instructions on how to proceed. The source text does not specify a particular action for consumers, as these are medical devices used in clinical settings.
The recalled product
- Product
- Sorin Stockert Heater-Cooler 3T, 120 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
- Manufacturer
- Sorin Group USA, Inc.
- Hazard
- Affected units
- 1,755
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 (1)
- Product code 16-02-85 Serial number 16S10958-16S15634
Distribution
Part of a larger recall action
This product is one of 6 recalled by Sorin Group USA, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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