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
- Company
- Livanova Usa
- Recall Initiated
- April 20, 2018
- Posted
- May 18, 2018
- Terminated
- February 5, 2025
- Recall Number
- Z-1901-2018
- Quantity
- 2408
- Firm Location
- Arvada, CO
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
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,
Lot / Code Info
Serial #: a) 16S10743 - 6S11708 b) 16S10772 - 16S16840 C) 16S10958 - 16S16847
Root Cause
Device Design
Action Taken
On 04/20/2018, a Medical Device Correction notice was sent to customers informing them to return devices less than ten years old. Returned devices will receive a deep cleaning service, which will reduce microbial contamination to HPC < 100 CFU/ml of water and NTM < 1 CFU/100ml.