ST¿CKERT HeaterCooler System 3T; Item Number 160281, HeaterCooler 3T, 240V/60Hz; Item Number ...

FDA Device Recall #Z-0682-2017 — Class II — August 1, 2014

Recall Summary

Recall Number Z-0682-2017
Classification Class II — Moderate risk
Date Initiated August 1, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Sorin Group USA, Inc.
Location Arvada, CO
Product Type Devices
Quantity 1,618 units in the US; 129 units outside of US

Product Description

ST¿CKERT HeaterCooler System 3T; Item Number 160281, HeaterCooler 3T, 240V/60Hz; Item Number 160282, HeaterCooler 3T, 208V/60Hz; Item Number 160285, HeaterCooler 3T, 120V/ 60Hz The Heater Cooler 3T is used with a St¿ckert S3 heart lung machine and / or any other heart lung machine featuring a separate temperature control for extracorporeal perfusion of durations up to 6 hours

Reason for Recall

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).

Distribution Pattern

Worldwide Distribution - US (Nationwide and Puerto Rico) and Internationally to Canada, Colombia, Ecuador, El Salvador, Germany, Honduras, Mexico, Saudi Arabia, Trinidad, and Tobago.

Lot / Code Information

All Serial Numbers

Other Recalls from Sorin Group USA, Inc.

Recall # Classification Product Date
Z-0076-2018 Class II FlexFlow Venous Cannula Model/Catalog Number 20... Sep 28, 2017
Z-2776-2017 Class II STOCKERT Heater-Cooler System 3T, 200V/50 Hz/60 Hz Jun 30, 2017
Z-2771-2017 Class II STOCKERT Heater-Cooler System 3T, 230 V Jun 30, 2017
Z-2775-2017 Class II STOCKERT Heater-Cooler System 3T, 120V/60 Hz Jun 30, 2017
Z-2773-2017 Class II STOCKERT Heater-Cooler System 3T, 208V/60 Hz Jun 30, 2017

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.