Sorin Group USA, Inc. - Coronary Artery Perfusion Cannula with Balloon - Class 2 Recall
Coronary Artery Perfusion Cannula with Balloon (part number CP-2200X). The Coronary Artery Perfusion Cannula with Balloon The Cannula consists of a single lumen vinyl tube provided for with a vinyl female luer connector bonded proximally and a vinyl cuff bonded distally. The cuff is pre-molded to its inflated configuration and is purposely positioned directly over a hole generated in the extruded tube for purposes of receiving the infused cardioplegia solution. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 9, 2016 Category: Medical Equipment Source Type: alerts
Sorin Group USA, Inc. - Aortic Arch Cannula - Class 2 Recall
Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6). The Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced (flexible) polyvinyl chloride tubing that terminates in an angled tip. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect. The Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consi...
Source: Medical Device Recalls - September 9, 2016 Category: Medical Equipment Source Type: alerts
NOVADAQ TECHNOLOGIES INC. - SK6000 PAQ drape pouch - Class 2 Recall
Sterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System (SPY 2000/2001)) The SPY Fluorescent Imaging System is intended to provide fluorescent images for the visual assessment of blood flow in vessels and related tissue perfusion during cardiovascular surgical procedures. For use in intraoperative visual assessment of the coronary vasculature and bypass grafts during coronary artery bypass (BABG) surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 9, 2016 Category: Medical Equipment Source Type: alerts
Datascope Corporation - Small Patient ECC Pack - Class 2 Recall
Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart surgery the HLM Tubing Sets with Bioline Coating are used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The main purpose of the HLM Tubing Sets with Bioline Coating is to connect the patient to the hear-lung machine and it s components. The HLM Tubing Sets with Bioline Coating are therefore a com...
Source: Medical Device Recalls - June 16, 2016 Category: Medical Equipment Source Type: alerts
Medtronic Perfusion Systems - Perfusion Tubing Pack - Class 3 Recall
Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I¿ H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack. This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass procedures (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 27, 2016 Category: Medical Equipment Source Type: alerts
Sorin Group USA, Inc. - CDl H/S Cuvette Perfusion Pack or Smart Perfusion Pack - Class 3 Recall
CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack. Product Usage: Heart/Lung Perfusion Pack is either a customized tubing pack built to user specifications or a stock tubing pack, designed for use during surgery requiring cardiopulmonary bypass. It is not designed for long-term use (greater than six hours). Perfusion Packs labeled as SMART¿ contain components that have an additive to improve blood compatibility. Non-SMART packs may contain some SMART tubing and/or connectors depending on the customer requirements. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 26, 2016 Category: Medical Equipment Source Type: alerts
Masimo Corporation - rainbow Reusable Sensors - Class 2 Recall
rainbow Reusable Sensors RAINBOW DCI-DC3, SpO2/SpCO/SpMet, 1/BX, Part No. 2201. RAINBOW DCI-dc8, SpO2/SpCO/SpMet, 1/BX, Part No. 2407. RAINBOW DCI, SpO2/SpCO/SpMet, 1/BX, Part No. 2696. RAINBOW DCIP, PED, SpO2/SpCO/SpMet, 1/BX, Part No. 2697. The rainbow DCI and DCI-P reusable sensors are indicated for spot check or continuous non-invasive monitoring of arterial saturation (SpO2), arterial carboxyhemoglobin saturation (SpCO), arterial methemoglobin (SpMet), and pulse rate. SpCO and SpMet accuracies were not validated under motion or low perfusion conditions. The rainbow DCI-dc and DCI-P-dc reusable sensors are indic...
Source: Medical Device Recalls - November 26, 2015 Category: Medical Equipment Source Type: alerts
Medtronic Perfusion Systems - Perfusion tubing Set - Class 2 Recall
Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Sterilized using Ethylene Oxide. The Tubing Pack design and components are specified by the user, they are packaged with consideration of setup efficiency and respect for the environment, and they are intended for use in the extracorporeal circuit during cardiopulmonary bypass procedures. Medtronic Tubing Packs can contain components with Carmeda BioActive Surface, Trillium BioSurface, Balance BioSurface or no coating. Sterile barrier for these packs is provided either by a Tyvek lid seal on the tray or by a header bag. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 13, 2015 Category: Medical Equipment Source Type: alerts
Terumo Cardiovascular Systems Corp - Terumo Cardiovascular Systems (CVS) - Class 2 Recall
Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack with FX25RE P/N: 7928-03 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures wher...
Source: Medical Device Recalls - September 19, 2015 Category: Medical Equipment Source Type: alerts
Terumo Cardiovascular Systems Corp - Terumo Cardiovascular Systems (CVS) - Class 2 Recall
Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack P/N: 74077-01 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute h...
Source: Medical Device Recalls - September 19, 2015 Category: Medical Equipment Source Type: alerts
Medtronic Perfusion Systems - MEDIVATORS HEMOCOR HPH700, HPH1400TS, HPH1000TS - Class 2 Recall
MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS. Enables the perfusionist to manage the patient's hematocrit and fluid status. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 5, 2015 Category: Medical Equipment Source Type: alerts
Medtronic Perfusion Systems - MEDTRONIC PERFUSION TUBING PACKS - Class 2 Recall
MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconentrators). Model # 7U65R2, 8C72R4, 6N21R2, BB7M38R11, TL2Q68R17, HY8R66R3, HY2U43R9, 8C72R4, BB5J59R19, 6B65R3, TL7M46R7, TL2Q68R17, 7U65R2, M074704B, M230002A, BB7M38Rll, M450013B, BB8N86R4, HY2U43R9, 8C72R4, M650123A, HY8R55R ,TL7M46R7, M971406C, M450013B, 7U65R2, M394415A, M450013B. Enables the perfusionist to manage the patient's hematocrit and fluid status. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 5, 2015 Category: Medical Equipment Source Type: alerts
Medtronic Perfusion Systems - Medtronic EOPA Arterial Cannula - Class 2 Recall
Medtronic EOPA¿ Arterial Cannula, Model # 77620. Lot: 2015060544 intended to deliver oxygenated blood to the heart during cardiopulmonary bypass procedures for up to 6 hours in duration. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 20, 2015 Category: Medical Equipment Source Type: alerts
Sorin Group USA, Inc. - STOCKERT HEATERCOOLER SYSTEM 3T - Class 2 Recall
Sorin Stockert Heater-Cooler 3T, 120 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 16, 2015 Category: Medical Equipment Source Type: alerts
Sorin Group USA, Inc. - STOCKERT HEATERCOOLER SYSTEM 3T - Class 2 Recall
Sorin Stockert Heater-Cooler 3T, 208 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 16, 2015 Category: Medical Equipment Source Type: alerts
