Sorin Stockert Heater-Cooler 3T Recalled for Potential Organism Colonization
Sorin Group USA is recalling 131 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) and a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Sorin Group USA, Inc. is recalling 131 units of the Sorin Stockert Heater-Cooler 3T, 200 V / 50Hz / 60 Hz. These devices are used for temperature control during extracorporeal perfusion of durations up to 6 hours. The affected units have serial numbers ranging from 16S12004 to 16S15385 and product code 16-02-95.
The recall was initiated because of the potential for 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.
The affected units were distributed worldwide, including nationwide in the United States and internationally to numerous countries. Healthcare facilities and users of these devices should verify if they possess the affected serial numbers and follow the manufacturer's instructions for proper disinfection and maintenance to mitigate the risk.
The recalled product
- Product
- Sorin Stockert Heater-Cooler 3T, 200 V / 50Hz / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
- Manufacturer
- Sorin Group USA, Inc.
- Hazard
- Affected units
- 131
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 16-02-95 Serial number 16S12004-16S15385
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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