SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.
Reported: April 17, 2019 Initiated: September 14, 2018 #Z-1099-2019
Product Description
SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.
Reason for Recall
For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).
Details
- Recalling Firm
- LivaNova USA Inc.
- Units Affected
- 6 devices
- Distribution
- US Distribution to states of: IN, MO, and OH.
- Location
- Arvada, CO
Frequently Asked Questions
What product was recalled? ▼
SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.. Recalled by LivaNova USA Inc.. Units affected: 6 devices.
Why was this product recalled? ▼
For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 17, 2019. Severity: Moderate. Recall number: Z-1099-2019.
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