Stockert Heater-Cooler System 3T

• • Terminated Z-1498-2020 FDA Class II ·initiated 24 Feb 2020

  The firm is providing validated cleaning and disinfection instructions in their revised operating instructions to reduce the risk of NTM contamination.

• • Terminated Z-0220-2020 FDA Class II ·initiated 1 Nov 2018

  The firm has become aware that due to a chemical reaction, the disinfectant/water preservative used to disinfect the device to inhibit/limit the growth micro-organisms, may be rendered ineffective. In addition, the firm is releasing a design upgrade to reduce the risk of potential emission of aerosols from the 3T.

• • Terminated Z-1099-2019 FDA Class II ·initiated 14 Sep 2018

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

• • Terminated Z-1901-2018 FDA Class II ·initiated 20 Apr 2018

  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.

• 6 recalls, same reason

  • Terminated Z-2774-2017 FDA Class II ·initiated 30 Jun 2017
  • Terminated Z-2776-2017 FDA Class II ·initiated 30 Jun 2017
  • Terminated Z-2775-2017 FDA Class II ·initiated 30 Jun 2017
  • Terminated Z-2773-2017 FDA Class II ·initiated 30 Jun 2017
  • Terminated Z-2772-2017 FDA Class II ·initiated 30 Jun 2017
  • Terminated Z-2771-2017 FDA Class II ·initiated 30 Jun 2017

  Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.

• 6 recalls, same reason

  • Terminated Z-2080-2015 FDA Class II ·initiated 15 Jun 2015
  • Terminated Z-2081-2015 FDA Class II ·initiated 15 Jun 2015
  • Terminated Z-2079-2015 FDA Class II ·initiated 15 Jun 2015
  • Terminated Z-2076-2015 FDA Class II ·initiated 15 Jun 2015
  • Terminated Z-2078-2015 FDA Class II ·initiated 15 Jun 2015
  • Terminated Z-2077-2015 FDA Class II ·initiated 15 Jun 2015

  Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per Instructions for Use.

• • Terminated Z-0682-2017 FDA Class II ·initiated 1 Aug 2014

  On August 1, 2014 Sorin Group USA, Inc. informed consignees via letter to review the disinfection and monitoring practices and to strictly adhere to the instructions in the Instructions for Use (IFU).

• • Terminated Z-1186-2016 FDA Class II ·initiated 15 Aug 2012

  On August 15, 2012, Sorin informed consignees via letter of changes made to create Version 12 of the Heater-Cooler 3T IFU. The revised IFU included enhancements to achieve water quality that meets the standard for German drinking water.

510(k) Number

K052601 ↗

FDA Product Code

DWC

Device Class

Class II

Regulation

21 CFR Part 870.4250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Modification to Stockert S5 System

  Class II

  FDA 510(k) K062396 Active Cleared 28 Sep 2006

• Modification to: Stockert S5 System

  Class II

  FDA 510(k) K071318 Active Cleared 6 Jul 2007

• Sorin C5 System; 85/C5 Mast Roller Pump System 150(1X Rp 150 and Control Panel with Connecting Cables); S5/C5 Mast Rolle

  Class II

  FDA 510(k) K103762 Active Cleared 20 Jan 2011

• Air Purge Control System for S5 System Model 23-45-05

  Class II

  FDA 510(k) K091007 Active Cleared 2 Jul 2009

• Xtra

  Class II

  FDA 510(k) K131553 Active Cleared 21 Mar 2014

• Sorin Connect

  Class II

  FDA 510(k) K170460 Active Cleared 8 Jun 2017

See all devices from Sorin Group Deutschland GmbH →