Z-1901-2018 Class II Terminated
FDA device recall Z-1901-2018 was initiated by LivaNova USA on Apr 20, 2018 and is designated Class II. Reason for recall: Firm is notifying customers that the Deep-Cleaning Service is now available in the United States. Stockert Heater-Cooler System 3T devices are suspected of microbial contamination and may contain… The recall status is terminated (terminated Feb 5, 2025). Affected quantity: 2408.
Recall Details
- Product Type
- Devices
- Report Date
- May 30, 2018
- Initiation Date
- Apr 20, 2018
- Termination Date
- Feb 5, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2408
Product Description
Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #: 16-02-85, 120 v/60 Hz
Reason for Recall
Firm is notifying customers that the Deep-Cleaning Service is now available in the United States. Stockert Heater-Cooler System 3T devices are suspected of microbial contamination and may contain visible biofilm.
Distribution Pattern
MN, TX, WA, OR, IL, OH, SC, AK, PA, CA, WI, GA, NJ, FL, AZ, KY, MS, MO, LA, AR, MA, MI, MT, CO, TN, NE, NC, VA, NV, HI, PR, WY, AL, OK, IN, CT, ME, IA, SC, KS, NM, SD, DC, MD, ND,
Code Information
Serial #: a) 16S10743 - 6S11708 b) 16S10772 - 16S16840 C) 16S10958 - 16S16847
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1901-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026