Bard Peripheral Vascular Inc - Economy Jamshidi Bone Marrow Biopsy and Aspiration Tray; 2) Economy Jamshidi Bone Marrow Biopsy Tra - Class 2 Recall
Catalog # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X 4"Biopsy/Aspiration needle, sterile, Qty: 10, Single Use Only, RX only. Exp. Date Lidocaine Vendor lot. CareFusion Intended use to aspirate marrow from either the sternum or the iliac crest. Intraosseous Infusion is recommended only in life-threatening emergencies where vascular access is critical and conventional forms of access are not available or are unobtainable. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 20, 2021 Category: Medical Devices Source Type: alerts
EYESALINE EMERGENCY EYEWASH (purified water) liquid [Honeywell Safety Products USA, Inc.]
Updated Date: Mon, 18 Oct 2021 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - October 18, 2021 Category: Drugs & Pharmacology Source Type: alerts
Abbott Molecular, Inc. - Alinity m Resp4Plex AMP Kit Assay - Class 1 Recall
Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 15, 2021 Category: Medical Devices Source Type: alerts
Abbott Molecular, Inc. - Alinity m SARSCoV2 Amp Kit Assay - Class 1 Recall
Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 15, 2021 Category: Medical Devices Source Type: alerts
EYESALINE EMERGENCY EYEWASH (purified water) liquid [Honeywell Safety Products USA, Inc.]
Updated Date: Wed, 13 Oct 2021 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - October 13, 2021 Category: Drugs & Pharmacology Source Type: alerts
EYESALINE EMERGENCY EYEWASH CONCENTRATE (water) concentrate [Honeywell Safety Products USA, Inc]
Updated Date: Wed, 13 Oct 2021 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - October 13, 2021 Category: Drugs & Pharmacology Source Type: alerts
Quidel Corporation - Class 2 Recall
Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyra Direct SARS-CoV-2 Assay is a real-time RT-PCR assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasal (NS), nasopharyngeal (NP), or oropharyngeal (OP) direct swab specimens from individuals suspected of COVID-19 by their healthcare provider (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 16, 2021 Category: Medical Devices Source Type: alerts
Versea Diagnostics LLC - Status COVID19/Flu Rapid Immunoassay - Class 2 Recall
Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenzas Type A, and Type B Antigens Simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2, influenza A and influenza B directly from nasopharyngeal swab specimens obtained from individuals, who are suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider, within the first five days of onset of symptoms. Emergency use of this test is limited to authorized laboratories. (CLIA Waived Laboratories) (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 4, 2021 Category: Medical Devices Source Type: alerts
Versea Diagnostics LLC - Healgen COVID19 IgG/IgM Rapid Test Cassette - Class 2 Recall
Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in human venous whole blood, plasma (Li+- heparin, K2-EDTA and sodium-citrate), and serum. Intended for use as 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. Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform moderate or high complexity te...
Source: Medical Device Recalls - September 4, 2021 Category: Medical Devices Source Type: alerts
AZURE BIOTECH INC - Fastep and Ecotest (authorized brand names for Assure COVID19 IgG/IgM Rapid Test Device) - Class 2 Recall
Assure COVID-19 IgG/IgM Rapid Test Device that include: 1) Pouch Label - FaStep Rapid Diagnostic Test *** Rapid Reliable Simple *** COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) *** For Emergency Use Authorization Only, Box Label - FaStep Rapid Diagnostic Test *** COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) *** For Emergency Use Authorization Only *** For in vitro diagnostic use only, and 2) Pouch Label - ECOTEST RAPID DIAGNOSTIC TEST *** /Rapid / Reliable / Simple/ *** COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) *** For Emergency Use Authorization Only, Box Label - ECO...
Source: Medical Device Recalls - April 17, 2021 Category: Medical Devices Source Type: alerts
CAIRE DIAGNOSTICS INC - Fenom Pro Asthma Monitor - Class 2 Recall
CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Product Usage: a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. Fenom Pro should not be used in critical care, emergency care or in anesthesiology. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 20, 2021 Category: Medical Devices Source Type: alerts
Ortho-Clinical Diagnostics, Inc. - Ortho Clinical Diagnostics VITROS Immunodiagnostic Products SARSCoV2 Antigen Reagent Pack - Class 2 Recall
VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used in combination with the VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal (NP) specimens. For emergency authorization use only (EAU). Product Code: 6199941. OUS Product. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 18, 2021 Category: Medical Devices Source Type: alerts
Ortho-Clinical Diagnostics, Inc. - Ortho Clinical Diagnistics VITROS Immunodiagnostic Products SARSCoV2 Antigen Reagent Pack - Class 2 Recall
VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro Diagnostic. The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used in combination with the VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal (NP) specimens. . For emergency authorization use only (EAU). Intended for Use in the United States Product Code: 6199949. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 18, 2021 Category: Medical Devices Source Type: alerts
VISBY MEDICAL INC - visby medical COVID19 Test kit - Class 2 Recall
visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitative detection of SARS-CoV-2 - Product Usage: The Visby Medical COVID-19 Test is only for use under the Food and Drug Administration s Emergency Use Authorization. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 13, 2021 Category: Medical Devices Source Type: alerts
Prytime Medical Devices, Inc. - ERREBOA PLUS Catheter - Class 2 Recall
PryTime Medical - ER-Reboa Plus Catheter, Ref: ER7232PLUS, Guidewire Free, Compatabel with 7Fr introducer Sheaths, Arterial Line, Rx Only, UDI: (01) 0 0850001 10505 7 - Product Usage: intended for temporary occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 24, 2020 Category: Medical Devices Source Type: alerts
