Radiometer Medical ApS - ABL 80 COOX SYSTEM - Class 2 Recall
ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 05700693938417 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 30, 2020 Category: Medical Devices Source Type: alerts
Siemens Healthcare Diagnostics Inc. - Class 2 Recall
Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN #10380062 - Product Usage: are intended for professional use in a laboratory environment only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 30, 2020 Category: Medical Devices Source Type: alerts
Siemens Healthcare Diagnostics Inc. - Class 2 Recall
Siemens IMMULITE 2000 XPi Immunoassay System - In vitro Chemistry Analyzer SMN #10373214 - Product Usage: are intended for professional use in a laboratory environment only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 30, 2020 Category: Medical Devices Source Type: alerts
Radiometer Medical ApS - ABL80 FLEX ANALYZER - Class 2 Recall
ABL80-FLEX-393-839 Box Label, REF 393-839, IVD, CE, UDI: 05700693938394 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 30, 2020 Category: Medical Devices Source Type: alerts
Ventana Medical Systems Inc - VENTANA HE 600 system - Class 2 Recall
Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environment includes anatomic pathology (AP) laboratories and histology facilities within hospital, clinic, reference, or private lab settings. The System is to be operated by qualified users in (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 6, 2020 Category: Medical Devices Source Type: alerts
Radiometer Medical ApS - ABL90 FLEX - Class 2 Recall
ABL90 FLEX, model no. 393-090; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 29, 2020 Category: Medical Devices Source Type: alerts
Radiometer Medical ApS - ABL90 FLEX PLUS - Class 2 Recall
ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 29, 2020 Category: Medical Devices Source Type: alerts
CME America, LLC - CMEAmerica BodyGuard Microset - Class 2 Recall
BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage: The system is intended for patients who require maintenance medications, PCA therapy, parenteral nutritional fluids, and general IV fluid therapy in hospital and home care environments. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 5, 2020 Category: Medical Devices Source Type: alerts
Radiometer Medical ApS - ABL 90 FLEX PLUS - Class 2 Recall
ABL90 FLEX PLUS Analyzer, Model Number 393-092 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 23, 2020 Category: Medical Devices Source Type: alerts
Radiometer Medical ApS - ABL90 FLEX - Class 2 Recall
ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 23, 2020 Category: Medical Devices Source Type: alerts
Gentell, Inc - Gentell Hydrogel Ag - Class 2 Recall
Gentell Hydrogel Ag 4oz. Tube, model no. - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Silver Antimicrobial Wound Dressing is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 6, 2020 Category: Medical Devices Source Type: alerts
Gentell, Inc - Gentell Hydrogel Ag - Class 2 Recall
Gentell Hydrogel Ag 2x2, model no GEN-11220 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 6, 2020 Category: Medical Devices Source Type: alerts
Gentell, Inc - Gentell Hydrogel Ag - Class 2 Recall
Gentell Hydrogel Ag 4x8, model no. GEN-11820 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 6, 2020 Category: Medical Devices Source Type: alerts
Gentell, Inc - Gentell Hydrogel Ag - Class 2 Recall
Gentell Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 6, 2020 Category: Medical Devices Source Type: alerts
Boston Scientific Corporation - LATITUDE Programming System - Class 2 Recall
Boston Scientific, LATITUDE Programming System, Model 3300 - Product Usage:The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generator (PG). Detailed software applications instructions can be found in the associated product literature for the PG being interrogated. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 4, 2020 Category: Medical Devices Source Type: alerts
