ALOCANE EMERGENCY BURN (lidocaine hydrochloride) gel [Quest Products, LLC.]
Updated Date: Tue, 15 Dec 2020 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - December 15, 2020 Category: Drugs & Pharmacology Source Type: alerts

Shimadzu Medical Systems - MobileDaRt Evolution - Class 2 Recall
Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, Made in Japan - Product Usage: The device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 5, 2020 Category: Medical Devices Source Type: alerts

Ortho Clinical Diagnostics Inc - VITROS Immunodiagnostic ProductsSARSCoV2 IgG Calibrator - Class 2 Recall
VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories-- Product Code (Unique Identifier): 6199920 (10758750033362) (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 14, 2020 Category: Medical Devices Source Type: alerts

North American Rescue LLC. - 4 Inch Flat Responder Emergency Trauma Dressing - Class 2 Recall
4 In. Flat Responder Emergency Trauma Dressing part number 30-0171, packaged in kits labeled as follows: a) M-FAK Mini First Aid Kit; Kit Product Code: 80-0890 b) M-FAK Mini First Aid Kit, with Bleeding Control Dressing; Kit Product Code: 80-0891 c) M-FAK Mini First Aid Kit, Advance; Kit Product Code: 80-0892 d) M-FAK Mini First Aid Kit, Basic; Kit Product Code: 80-0913 e) M-FAK Mini First Aid Kit; Kit Product Code: 80-0914 f) Trauma and First Aid Kit; Kit Product Code: 80-0947 g) Trauma and First Aid Kit; Kit Product Code: 80-0948 h) Trauma and First Aid Kit; Kit Product Code: 80-1047 i) Trauma and First Aid Kit ...
Source: Medical Device Recalls - September 26, 2020 Category: Medical Devices Source Type: alerts

Ge Healthcare - OEC 9800, OEC 9900 Elite - Class 2 Recall
The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care and emergency room procedures. The GE OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures, and is also intended for cholangiography...
Source: Medical Device Recalls - August 28, 2020 Category: Medical Devices Source Type: alerts

Precision Valve & Automation,Inc - PVA, PREVENT - Class 2 Recall
PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19 respiratory failure. This motorized device automatically compresses a resuscitator bag to provide air to the lungs of a COVID-19 patient, eliminating the human error and fatigue that results from manual actuation. PREVENT is indicated for emergency resuscitation with appropriate patient monitoring on adult patients that require mechanical respiratory support. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 15, 2020 Category: Medical Devices Source Type: alerts

HF Acquisition Co., LLC - NARCAN Nasal Spray - Class 2 Recall
Narcan Nasal spray in Emergency kits. item number 1010300 STAT KIT # SM30 ; Emergency Medical Kit P/N: 1008670 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 13, 2020 Category: Medical Devices Source Type: alerts

HF Acquisition Co., LLC - NARCAN Nasal Spray - Class 2 Recall
Narcan Nasal spray in Emergency kits, item number 1010300 STAT KIT # 550 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 13, 2020 Category: Medical Devices Source Type: alerts

HF Acquisition Co., LLC - Emergency Kit SM 7 w/ NARCAN Nasal Spray - Class 2 Recall
Narcan Nasal spray, item number 1010300 in Emergency kits. Kit Model : SM 7, emergency kit HealthFirst, P/N: 1008150; Manufactured by HF Acquisition Co. LLC, 11629 49th Place West/Mukilteo, WA 98275, HealthFirst.com; Store at Room Temperature. 9036-2v.5 08/2017 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 13, 2020 Category: Medical Devices Source Type: alerts

HF Acquisition Co., LLC - HealthFirst Emergency Kit SM 7 - Class 2 Recall
HealthFirst Emergency Medical Kit, Model SM 7, P/N: 1008150; Manufactured by HF Acquisition Co. LLC, 11629 49th Place West/Mukilteo, WA 98275, HealthFirst.com; Store at Room Temperature. 9036-2v.5 08/2017 containing various products to include Narcan Nasal spray, item number 1010300 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 13, 2020 Category: Medical Devices Source Type: alerts

HF Acquisition Co., LLC - STAT KIT Model 550 - Class 2 Recall
STAT KIT Model 550 Emergency Medical Kit P/N: 1009580 containing various products to include Narcan Nasal spray, item number 1010300 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 13, 2020 Category: Medical Devices Source Type: alerts

HF Acquisition Co., LLC - STAT KIT Emergency Medical Kit - Class 2 Recall
STAT KIT, Model SM30 ; Emergency Medical Kit P/N: 1008670 containing various products to include Narcan Nasal spray, item number 1010300 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 13, 2020 Category: Medical Devices Source Type: alerts

HF Acquisition Co., LLC - STAT KIT 550AI - Class 2 Recall
STAT KIT Model 550AI Emergency Medical Kit. P/N: 1010830 containing various products to include Narcan Nasal spray, item number 1010300 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 13, 2020 Category: Medical Devices Source Type: alerts

HF Acquisition Co., LLC - NARCAN Nasal Spray - Class 2 Recall
Narcan Nasal spray item number 1010300 in Emergency kits, STAT KIT # 550AI (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 13, 2020 Category: Medical Devices Source Type: alerts

HF Acquisition Co. LLC - STAT KIT Z1000 Emergency Medical Kit - Class 2 Recall
STAT KIT Z-1000 emergency medical kit HealthFirst - Product Usage: is intended to prepare physicians with advanced cardiac life support devices and medications to respond to cardiopulmonary medical emergencies until EMS arrives. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 11, 2020 Category: Medical Devices Source Type: alerts