Sorin Stockert Heater-Cooler 3T Recalled for Potential Organism Colonization
Sorin Group USA, Inc. is recalling 2,837 Sorin Stockert Heater-Cooler 3T units due to potential colonization of organisms, 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) in 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 2,837 units of the Sorin Stockert Heater-Cooler 3T, 230 V. This device is used for temperature control during extracorporeal perfusion of durations up to 6 hours. The affected units have serial numbers ranging from 16S10027 to 16S15641 and product code 16-02-80.
The recall is issued because of the potential colonization of organisms, including Mycobacteria, in the devices. This risk exists if proper disinfection and maintenance are not performed according to the Instructions for Use. The agency has classified this as a Class II recall.
The devices were distributed worldwide, including nationwide in the United States and internationally to numerous countries. Users of these devices should contact Sorin Group USA, Inc. for instructions on proper disinfection and maintenance to prevent potential colonization.
The recalled product
- Product
- Sorin Stockert Heater-Cooler 3T, 230 V Temperature control for extracorporeal perfusion of durations up to 6 hours.
- Manufacturer
- Sorin Group USA, Inc.
- Hazard
- Affected units
- 2,837
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 16-02-80 Serial number 16S10027-16S15641
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.
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