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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial numbers 16S13187, 16S14887, 16S15335, 16S15336, 16S15337, and 16S11877.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- LivaNova USA Inc.
- Reason for Recall:
- For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
Serial numbers 16S13187, 16S14887, 16S15335, 16S15336, 16S15337, and 16S11877.
Distribution:
Distributed in: US, IN, MO, OH
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1099-2019
Related Recalls
Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed position, which may result in patients returning to baseline seizure frequency or depressive symptoms and in the longer term, patients may be required to undergo generator replacement surgery to replace their device.
Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed position, which may result in patients returning to baseline seizure frequency or depressive symptoms and in the longer term, patients may be required to undergo generator replacement surgery to replace their device.
Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.