SORIN Heater-Cooler System 3T recall
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…
Why was SORIN Heater-Cooler System 3T recalled?
For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial numbers 16S13187, 16S14887, 16S15335, 16S15336, 16S15337, and 16S11877.
- Product
- 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…
- Recalling firm
- LivaNova USA Inc.
- Quantity
- 6 devices
- Distribution
- US Distribution to states of: IN, MO, and OH.
- Recall date
- April 17, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)