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U.S. Department of Health and Human Services

Class 2 Device Recall Stockert HeaterCooler System 3T

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  Class 2 Device Recall Stockert HeaterCooler System 3T see related information
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 and Original Applicant = SORIN GROUP DEUTSCHLAND GMBH
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