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 #: 1

FDA device recall Z-1901-2018 · posted 2018-05-18 · Terminated

Recall details

Recalling firm

LivaNova USA

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.

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.

Root cause

Device Design

Status

Terminated

Product code

DWC

Quantity affected

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,

Date initiated

2018-04-20

Date posted

2018-05-18

Date terminated

2025-02-05

Location

Arvada, CO

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