Terumo Cardiovascular Systems Corporation - Terumo Advanced Perfusion System 1 - Class 2 Recall
Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801764 (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 26, 2018 Category: Medical Devices Source Type: alerts
Terumo Cardiovascular Systems Corporation - Terumo Advanced Perfusion System 1 - Class 2 Recall
Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801763 (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 26, 2018 Category: Medical Devices Source Type: alerts
SPS Sterilization, Inc - Aortic Perfusion Cannula - Class 2 Recall
Edwards Lifesciences Aortic Perfusion Cannula, 24F x 30CM, resterilized. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 14, 2018 Category: Medical Devices Source Type: alerts
SPS Sterilization, Inc - Optisite Arterial Perfusion Cannula - Class 2 Recall
Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, resterilized. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 14, 2018 Category: Medical Devices Source Type: alerts
ZINC INJECTABLE A 1MG/ML, SOLUTION INJECTABLE POUR PERFUSION (Zinc) Injection, Solution [Laboratoire Aguettant]
Updated Date: Aug 14, 2018 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - August 14, 2018 Category: Drugs & Pharmacology Source Type: alerts
Medela Inc - Invia Motion Negative Pressure Wound Therapy System. - Class 2 Recall
Invia Motion Negative Pressure Wound Therapy System. Labeled as: a. Endure Negative Pressure Wound Therapy (Model 087.4010); b. 15 Days Negative Pressure Wound Therapy (Model 087.4012); c. 60 Days Negative Pressure Wound Therapy (Model 087.4014) Product Usage: The Invia Motion Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a suction device (NPWT) as it creates 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 r...
Source: Medical Device Recalls - July 24, 2018 Category: Medical Devices Source Type: alerts
Terumo Cardiovascular Systems Corporation - Terumo Advanced Perfusion System 1 Flow Module - Class 2 Recall
Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow sensor and the system. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 21, 2018 Category: Medical Devices Source Type: alerts
Boston Scientific Corporation - ReEntry Malecot Nephrostomy Catheter Set - Class 2 Recall
Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101050, GTIN: 08714729192268 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion study (Whitaker test) Therapeutic Indications: " Nephrostomy catheter drainage " Perfusion chemolysis of renal stones " Percutaneous nephrolithotomy " Percutaneous resection and coagulation of urothelial tumors (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 19, 2018 Category: Medical Devices Source Type: alerts
Boston Scientific Corporation - Percutaneous Access Set - Class 2 Recall
Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion study (Whitaker test) Therapeutic Indications: " Nephrostomy catheter drainage " Perfusion chemolysis of renal stones " Percutaneous nephrolithotomy " Percutaneous resection and coagulation of urothelial tumors (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 19, 2018 Category: Medical Devices Source Type: alerts
Boston Scientific Corporation - Malecot Nephrostomy Catheter Set, - Class 2 Recall
Malecot Nephrostomy Catheter Set, Product Number: M0064101010, GTIN: 08714729005278 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion study (Whitaker test) Therapeutic Indications: " Nephrostomy catheter drainage " Perfusion chemolysis of renal stones " Percutaneous nephrolithotomy " Percutaneous resection and coagulation of urothelial tumors (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 19, 2018 Category: Medical Devices Source Type: alerts
Boston Scientific Corporation - ReEntry Malecot Nephrostomy Catheter Set - Class 2 Recall
Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101040, GTIN: 08714729008446 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion study (Whitaker test) Therapeutic Indications: " Nephrostomy catheter drainage " Perfusion chemolysis of renal stones " Percutaneous nephrolithotomy " Percutaneous resection and coagulation of urothelial tumors (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 19, 2018 Category: Medical Devices Source Type: alerts
Boston Scientific Corporation - Malecot Nephrostomy Catheter Set - Class 2 Recall
Malecot Nephrostomy Catheter Set, Product Number: M0064101000, GTIN: 08714729005261 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion study (Whitaker test) Therapeutic Indications: " Nephrostomy catheter drainage " Perfusion chemolysis of renal stones " Percutaneous nephrolithotomy " Percutaneous resection and coagulation of urothelial tumors (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 19, 2018 Category: Medical Devices Source Type: alerts
Medtronic Perfusion Systems - BIO CAL(R) 370/370I Temperature Controller - Class 2 Recall
BIO CAL(R) Temperature Controller, Models: (a) 370, (b) 370I Product Usage: The BIO CAL(R) (unit) is a thermal transfer module designed to control patient blood temperature during cardiopulmonary bypass procedures when heating or cooling of the blood is desired. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 7, 2018 Category: Medical Devices Source Type: alerts
LivaNova USA - Sorin Group Smart Perfusion Pack EPack - Class 3 Recall
Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, Inc., Arvada, CO. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 22, 2018 Category: Medical Devices Source Type: alerts
Medtronic Perfusion Systems - Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 - Class 2 Recall
Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 The AFFINITY(R) NT Cardiotomy/Venous Reservoir (CVR) with Filter is a single used device designed to collect and store blood during extracorporeal circulation. Venous blood is collected and de foamed while cardiotomy blood is collected, de foamed and filtered before mixing with the venous blood. The AFFINITY(R) NT Cardiotomy/Venous Reservoir (CVR) with filter is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures for up to 6 hours in duration. (Source: ...
Source: Medical Device Recalls - February 21, 2018 Category: Medical Devices Source Type: alerts
