Home / Recalls / LivaNova USA / Z-1901-2018

Z-1901-2018 Class II Terminated

Recalled by LivaNova USA — Arvada, CO

Recall Details

Product Type
Devices
Report Date
May 30, 2018
Initiation Date
April 20, 2018
Termination Date
February 5, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2408

Product Description

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

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.

Distribution Pattern

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,

Code Information

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

Other recalls by LivaNova USA

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  • Z-1072-2025 Class II — SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy (December 12, 2024)
  • Z-1073-2025 Class II — SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst S (December 12, 2024)
  • Z-0532-2022 Class II — Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 3 (December 2, 2021)
  • Z-0535-2021 Class II — VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of (November 12, 2020)
  • Z-0462-2021 Class II — VNS Therapy¿ AspireSR¿ Generator (September 28, 2020)
  • Z-2443-2020 Class II — Sterile Disposable Connectors ASY CONN Y 1/2X1/2X3/8 STR 24. REF/ GTIN for Inser (April 24, 2020)
  • Z-2449-2020 Class II — Sterile Disposable Connectors ASY ASY STR CONN 3/8 STRLE 24 REF/ GTIN for Insert (April 24, 2020)
  • Z-2446-2020 Class II — Sterile Disposable Connectors ASY STR CONN 3/16 STRLE 24. REF/ GTIN for Insert L (April 24, 2020)