August 2, 2023Medical DevicesFDA
Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the
Hazard: May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).
August 2, 2023Medical DevicesFDA
Datascope Corp. recalls REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in t
Hazard: During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.
August 2, 2023Medical DevicesFDA
Datascope Corp. recalls LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta
Hazard: During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.
August 2, 2023Medical DevicesFDA
Datascope Corp. recalls SENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the
Hazard: During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.
August 2, 2023Medical DevicesFDA
Datascope Corp. recalls SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in th
Hazard: During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.
August 2, 2023Medical DevicesFDA
Datascope Corp. recalls MEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta
Hazard: During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.
August 2, 2023Medical DevicesFDA
Datascope Corp. recalls MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta
Hazard: During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.
August 2, 2023Medical DevicesFDA
Datascope Corp. recalls TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta
Hazard: During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.
August 2, 2023Medical DevicesFDA
Datascope Corp. recalls SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aor
Hazard: During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.
August 2, 2023Medical DevicesFDA
Datascope Corp. recalls YAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provide counter pulsation therapy in the aorta.
Hazard: During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.
August 2, 2023Medical DevicesFDA
Qiagen GmbH recalls QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-C
Hazard: If cartridges of the affected Serial numbers (SNs) are used, in most cases, the error codes 0xY0003EA and 0xY00045A (where Y is a number between 1 and 4) that lead to a run abortion will occur and no results will be reported
August 2, 2023Medical DevicesFDA
Hamilton Medical, Inc. recalls HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and pediatr
Hazard: Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.
August 2, 2023Medical DevicesFDA
Hamilton Medical, Inc. recalls HAMILTON C2 Ventilator Is intended to provide positive pressure ventilatory support to adults and pediatrics, and opt
Hazard: Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.
August 2, 2023Medical DevicesFDA
Hamilton Medical, Inc. recalls HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pressure ventilatory sup
Hazard: Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.
August 2, 2023Medical DevicesFDA
Hamilton Medical, Inc. recalls HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory support to adults a
Hazard: Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.
July 26, 2023Medical DevicesFDA
Digisonics, Inc recalls Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software
Hazard: Software issue
July 26, 2023Medical DevicesFDA
Materialise N.V. recalls MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched dev
Hazard: The wrong tibia guide was included intended for a different patient case.
July 26, 2023Medical DevicesFDA
UFSK - International OSYS Gmbh recalls UFSK Treatment chair 500 XLE- Treatment chair for positioning and support of the patient during diagnostic and therapeut
Hazard: Service life of the electrical seat part drive of the treatment chair may be shortened unexpectedly after several years of use due to a potential wear-related reduction in the self-locking of the drive and may remain undetected. A worsened self-locking of the seat drive can lead to overriding the drive s end position when positioning the patient with the seat part in an inclined position
July 26, 2023Medical DevicesFDA
Ascensia Diabetes Care US, Inc. recalls Contour¿ next GEN Blood Glucose Monitoring System
Hazard: Ascensia Diabetes Care has determined through customer complaints that 580 of 2900 meters from lot number DM01T033P are reconfigured from mg/dL to mmol/L. Among them, 579 meters distributed in the United States were packaged into the meter kit and had incorrect factory-set unit of measure where the meters display glucose results in mmol/L rather than mg/dL. The standard unit of measurement for the United States is mg/dL. If a consumer does not notice the incorrect unit of measurement, it is possible that the meters glucose measurement will be read as a lower blood glucose measurement than expected, and this may result in the patients glucose level remaining high, which can potentially lead to an injury requiring immediate medical intervention.
July 26, 2023Medical DevicesFDA
Cytocell Ltd. recalls RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a
Hazard: DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.
July 26, 2023Medical DevicesFDA
Cytocell Ltd. recalls RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating
Hazard: DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.
July 26, 2023Medical DevicesFDA
Baxter Healthcare Corporation recalls GEM FLOW COUPLER Monitor, PN 5156-00000-011
Hazard: An issue was identified where the LCD monitor display may not indicate the correct active channel. The issue occurs when the monitor is turned on using battery power, and channel B was selected as the last active channel prior to powering down.
July 26, 2023Medical DevicesFDA
Medtronic Neurosurgery recalls Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105; DUR
Hazard: Dura regeneration matrix may have out-of-specification endotoxin levels due to issues with in-process and finished goods endotoxin testing, which may present clinically with signs and symptoms of an acute inflammatory process, comparable to infection.
July 26, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000
Hazard: The scissors were manufactured without a tip protector resulting in the scissors breaking through the semi-rigid plastic tray compromising sterility.
July 26, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) TOTAL JOINT, Model Number CDS9
Hazard: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
July 26, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: KIT,SUCTION CATH,14FR W/WATER, Mo
Hazard: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
July 26, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: BREAST BIOPSY TRAY, Model Number
Hazard: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
July 26, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC INFANT INSERTION PACK, Mod
Hazard: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
July 26, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PROBE COVER PACK, Model Number
Hazard: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
July 26, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL LINE START KIT , Mode
Hazard: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.