medical Class II Updated 2018-05-30

LivaNova USA recalls Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02

Recalled 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

Hazard / Issue

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.

Issued by

FDA

Affected States: 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, WY, AL, OK, IN, CT, ME, IA, KS, NM, SD, DC, MD, ND

Lot/Code Info: Serial #: a) 16S10743 - 6S11708 b) 16S10772 - 16S16840 C) 16S10958 - 16S16847

View official government recall

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