Recall Z-1901-2018
LivaNova USA · initiated April 20, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: Serial #: a) 16S10743 - 6S11708 b) 16S10772 - 16S16840 C) 16S10958 - 16S16847
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.
FDA-determined 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.
Details
- Recall number
- Z-1901-2018
- Initiated
- April 20, 2018
- Posted by FDA
- May 18, 2018
- Terminated
- February 5, 2025
- Product code
- DWC – Controller, Temperature, Cardiopulmonary Bypass
- Quantity
- 2408
- 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,
- Recalling firm
- LivaNova USA, Arvada, CO