Cook Inc. - Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy Stent Set - Class 2 Recall
Percutaneous Neonatal Pigtail Nephrostomy Set, Reference Part Number 080106, Order Number G14508. The set contains a 22 gage, 5 cm Chiba Needle; an 18 gage, 5 cm trocar needle; an .038-inch (.97 mm) diameter, 30 cm PTFE-coated stainless steel; a 5, 6, and 7 French, 10 cm radiopaque dilator; a 6 French, 7 cm radiopaque pigtail catheter; a retention disc with pull tie; and a 10 French, 10 cm clear, polyvinylchloride connecting tube with one-way stopcock. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 15, 2020 Category: Medical Devices Source Type: alerts
Getinge Group Logistics America, LLC - Servoi - Class 2 Recall
Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage: intended for general and critical ventilator care, and it can be used for low end to high end intensive care, in different configurations. It supports a variety of breathing modes and can be used for Neonates, Pediatric and Adults. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 10, 2020 Category: Medical Devices Source Type: alerts
Covidien, LP - Endo GIA Auto Suture Universal Articulating Loading - Class 2 Recall
Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code 030451 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 2, 2020 Category: Medical Devices Source Type: alerts
Covidien, LP - Endo GIA Auto Suture Universal Articulating Loading - Class 2 Recall
Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 2, 2020 Category: Medical Devices Source Type: alerts
Covidien, LP - Endo GIA Auto Suture Universal Articulating Loading - Class 2 Recall
Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 3.5 mm, Item Code 030455 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 2, 2020 Category: Medical Devices Source Type: alerts
Covidien, LP - Endo GIA Auto Suture Universal Articulating Loading - Class 2 Recall
Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 2, 2020 Category: Medical Devices Source Type: alerts
Covidien, LP - Endo GIA Auto Suture Universal Articulating Loading - Class 2 Recall
Endo GIA Auto Suture Universal Articulating Loading Unit 60 mm - 3.5 mm, Item Code 030458 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 2, 2020 Category: Medical Devices Source Type: alerts
Covidien, LP - Endo GIA Auto Suture Universal Articulating Loading - Class 2 Recall
Endo GIA Auto Suture Universal Loading Unit, Item Code 030457 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 2, 2020 Category: Medical Devices Source Type: alerts
Covidien, LP - Endo GIA Auto Suture Universal Articulating Loading - Class 2 Recall
Covidien Best Practices Procedure Kits containing Auto Suture Endo GIA Universal Loading Units, Parent Codes 00Z2760 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 2, 2020 Category: Medical Devices Source Type: alerts
Covidien, LP - Endo GIA Auto Suture Universal Articulating Loading - Class 2 Recall
Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 2, 2020 Category: Medical Devices Source Type: alerts
Covidien, LP - Endo GIA Auto Suture Universal Articulating Loading - Class 2 Recall
Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 2, 2020 Category: Medical Devices Source Type: alerts
CareFusion 303, Inc. - BD Alaris System - Class 2 Recall
BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2) and respiratory rate (RR). The EtCO2 module and disposables are indicated for use with intubated and nonintubated adult, pediatric and neonatal patients. It is not intended for direct connection to ventilator or breathing systems. Only one EtCO2 module can be connected to the Alaris System. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 4, 2020 Category: Medical Devices Source Type: alerts
Maquet Cardiovascular Us Sales, Llc - Holder HKHZ 19 for use with Quadroxi and QuadroxiD Neonatal / Pediatric Oxygenators - Class 2 Recall
Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxygenators, Model Number: 701047495 - Product Usage: The Holder HKHZ 19 is an accessory to QUADROX i and QUADROX iD Neonatal / Pediatric oxygenator and is being used as a single holder for QUADROX i and QUADROX iD Neonatal / Pediatric Oxygenator and can also be used in combination with the holder's arm (016061) to use in cardiopulmonary bypass procedures (CPB) in a pediatric patient population. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 13, 2020 Category: Medical Devices Source Type: alerts
Smith & Nephew, Inc. - PERILOC TARGETER - Class 2 Recall
PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usage: used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC plates and screws are indicated for fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus and clavicle. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 11, 2020 Category: Medical Devices Source Type: alerts
Shanghai United Imaging Healthcare Co., Ltd. - uDR 596i - Class 2 Recall
uDR 596i Digital Medical X-Ray Imaging System - Product Usage: intended to use by a qualified/ trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 8, 2020 Category: Medical Devices Source Type: alerts
