| Class 2 Device Recall Stockert HeaterCooler System 3T | |
Date Initiated by Firm | April 20, 2018 |
Date Posted | May 18, 2018 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1901-2018 |
Recall Event ID |
80072 |
510(K)Number | K052601 |
Product Classification |
Controller, temperature, cardiopulmonary bypass - Product Code DWC
|
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 |
Code Information |
Serial #: a) 16S10743 - 6S11708 b) 16S10772 - 16S16840 C) 16S10958 - 16S16847 |
Recalling Firm/ Manufacturer |
LivaNova USA 14401 W 65th Way Arvada CO 80004-3503
|
For Additional Information Contact | Joan Ceasar 281-228-7260 |
Manufacturer 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 2 | Device Design |
Action | 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. |
Quantity in Commerce | 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, |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
510(K) Database | 510(K)s with Product Code = DWC
|
|
|
|