Z-1099-2019 Class II Terminated
FDA device recall Z-1099-2019 was initiated by LivaNova USA Inc. on Sep 14, 2018 and is designated Class II. Reason for recall: For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM). The recall status is terminated (terminated Sep 14, 2022). Affected quantity: 6 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 17, 2019
- Initiation Date
- Sep 14, 2018
- Termination Date
- Sep 14, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 devices
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).
Distribution Pattern
US Distribution to states of: IN, MO, and OH.
Code Information
Serial numbers 16S13187, 16S14887, 16S15335, 16S15336, 16S15337, and 16S11877.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1099-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026