Sorin Group USA, Inc. - SMART PERFUSION PACK, NEONATE/PEDIATRIC - Class 2 Recall
STERILE SAMPLE SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127703, STERILE EO, Rx Only, 1 EA (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 30, 2017 Category: Medical Devices Source Type: alerts
Sorin Group USA, Inc. - SMART PERFUSION PACK, INSPIRE 8FS - Class 2 Recall
NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS, REF 044043700, 1 EA, NOT FOR CLINICAL USE (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 30, 2017 Category: Medical Devices Source Type: alerts
Sorin Group USA, Inc. - SMART PERFUSION PACK, SMART 1/4 PEDS PACK - Class 2 Recall
SORIN GROUP, SMART PERFUSION PACK, SMART 1/4" PEDS PACK, REF 627262502, STERILE EO, Rx Only, 1 EA (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 30, 2017 Category: Medical Devices Source Type: alerts
Sorin Group USA, Inc. - SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA3D - Class 2 Recall
SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA-3D, (a) REF 044042600 AND (b) REF 044011200, STERILE EO, Rx Only, 1 EA (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 30, 2017 Category: Medical Devices Source Type: alerts
Sorin Group USA, Inc. - SMART PERFUSION PACK, INSPIRE 8S - Class 2 Recall
SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Only, 1 EA (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 30, 2017 Category: Medical Devices Source Type: alerts
Sorin Group USA, Inc. - SMART PERFUSION PACK, PUMP AND TABLE PACK - Class 2 Recall
SORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK, REF 627374101, STERILE EO, Rx Only, 1 EA (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 30, 2017 Category: Medical Devices Source Type: alerts
KCI USA, INC. - Negative Pressure Wound Therapy Systems - Class 2 Recall
1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Part Number M8275093/5). The InfoV.A.C. and V.A.C.ULTA Negative Pressure Wound Therapy Systems are integrated wound management systems for use in acute, and extended and care settings. They are intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include chronic, acute, traumatic, subacute, and dehisced wounds, par...
Source: Medical Device Recalls - May 31, 2017 Category: Medical Devices Source Type: alerts
Datascope Corporation - Maquet Inc. - Class 2 Recall
Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number: 709000058 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 heart-lung machine and it s components. The HLM Tubing Sets with Bio...
Source: Medical Device Recalls - March 24, 2017 Category: Medical Equipment Source Type: alerts
Terumo Cardiovascular Systems Corporation - Level Sensor II Gel Pads - Class 2 Recall
Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads Product Usage: Level sensor pads are used to attach the level sensors to a hard shell reservoir. includes coupling gel. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 15, 2017 Category: Medical Equipment Source Type: alerts
Terumo Cardiovascular Systems Corporation - Level Sensor II Pads - Class 2 Recall
Terumo Advanced Perfusion System 1-Level Sensor II Pads, Product Usage: Ultrasonic couplant used to facilitate the transmission of sound energy between the level sensor and the reservoir. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 15, 2017 Category: Medical Equipment Source Type: alerts
Medtronic Inc - Affinity Fusion Oxygenator w/ Arterial Filter, cardiotomy/Venous Reservoir, perfusion tubing packs - Class 2 Recall
Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion cardiotomy/Venous Reservoir, Perfusion Tubing Packs The Affinity Fusion Oxygenator with Integrated Arterial Filter with or without the Cardiotomy/Venous Reservoir with Balance¿1 Biosurface is intended for use in an extracorporeal perfusion circuit to oxygenate blood and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 21, 2016 Category: Medical Equipment Source Type: alerts
Sorin Group USA, Inc. - HeaterCooler 3T - Class 2 Recall
ST¿CKERT Heater Cooler System 3T; Item Number 16 02 81, Heater Cooler 3T, 240V/60Hz; Item Number 16 02 82, Heater Cooler 3T, 208V/60Hz; Item Number 16 02 85, Heater Cooler 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 (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 2, 2016 Category: Medical Equipment Source Type: alerts
ICU Medical, Inc. - Transpac IV Monitoring Kit - Class 2 Recall
PERFUSION PUMP KIT FOR MEMORIAL HOSP., Item No. 46070-79 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 16, 2016 Category: Medical Equipment Source Type: alerts
ICU Medical, Inc. - Transpac IV Monitoring Kit - Class 2 Recall
PERFUSION KIT FOR UNIV. OF IOWA, Item No. 46091-51 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 16, 2016 Category: Medical Equipment Source Type: alerts
ICU Medical, Inc. - Transpac IV Monitoring Kit - Class 2 Recall
PERFUSION KIT W/03ML FLUSH DEVICE FOR NE REGIONAL MED. CTR, Item No. 46097-33 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 16, 2016 Category: Medical Equipment Source Type: alerts
