Home / Recalls / LivaNova USA Inc. / Z-1099-2019

Z-1099-2019 Class II Terminated

Recalled by LivaNova USA Inc. — Arvada, CO

Recall Details

Product Type
Devices
Report Date
April 17, 2019
Initiation Date
September 14, 2018
Termination Date
September 14, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6 devices

Product Description

SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.

Reason for Recall

For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).

Distribution Pattern

US Distribution to states of: IN, MO, and OH.

Code Information

Serial numbers 16S13187, 16S14887, 16S15335, 16S15336, 16S15337, and 16S11877.

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  • 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-2448-2020 Class II — Sterile Disposable Connectors ASY S CONN 3/16X1/8 RDR ANLD24 REF/ GTIN for Inser (April 24, 2020)
  • Z-2457-2020 Class II — Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert La (April 24, 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)