Smith + Nephew (NYSE:SNN) issued an urgent field safety notice to warn of issues with multiple suture-based repair systems. The safety notice said that the company identified a manufacturing issue in the product packaging process that could result in an improper or incomplete seal of the pouch surrounding the sterile product. If that happens, it could […]
BD has another Class I infusion device recall
The FDA issued another Class I recall designation for the BD Alaris from Becton Dickinson (NYSE:BDX), this time for potentially incorrect displays. Recalled products include the BD Alaris syringe module (model 8110) and BD Alaris PCA module (model 8120), and the BD Alaris syringe/PCA sizer sensor replacement kit (P/N 122786). Affected products related to the infusion […]
BD has a serious recall of some Alaris System infusion pumps with stuck keys
The FDA announced today that the August recall of a Becton Dickinson (NYSE:BDX) Alaris PC unit is Class I, the most serious kind. Initiated on Aug. 4, 2020, the recall pertains to the BD Alaris PC unit 8015 and five affected keypad replacement kits manufactured between April 7, 2017 and June 15, 2020 and distributed between […]
DHS warns on Philips patient monitoring systems
The U.S. Department of Homeland Security warned of several vulnerabilities in patient monitors made by Royal Philips (NYSE:PHG). Amsterdam-based Philips’ Patient Information Center iX, PerformanceBridge Focal Point, IntelliVue Patient Monitors MX100, MX400-MX850 and MP2-MP90 and IntelliVue X2 and X3 were all listed among the affected equipment in a DHS release. Potential vulnerabilities within those devices include […]
BD says 3 serious issues related to Alaris recall
Becton Dickinson (NYSE:BDX) today offered an update confirming three separate issues related to the recall of its BD Alaris infusion pumps. Three situations described in the recall, which was announced on June 30, were designated as FDA Class I recalls (the most serious kind), meaning that there is reasonable probability that use of the product will […]
Smiths Medical has a serious infusion pump recall
Smiths Medical announced that it has become aware of an issue in which certain Medfusion syringe pumps may not operate as expected. Minneapolis-based Smiths Medical said in a news release that certain Medfusion 3500 and 4000 syringe pumps with specific firmware versions may provide over-delivery or under-delivery of a bolus or loading dose when one […]
FDA warns on false results for Thermo Fisher TaqPath COVID-19 testing kit
The FDA today issued a warning for labs and healthcare providers due to a risk of false results with a Thermo Fisher Scientific (NYSE:TMO) COVID-19 test kit. Results from the Thermo Fisher TaqPath COVID-19 Combo Kit may be false, based on two issues related to the test kit and the associated Applied Biosystems COVID-19 interpretive software, […]
FDA revokes Autobio antibody test EUA
The FDA issued a letter announcing that it revoked the emergency use authorization (EUA) for a COVID-19 test from Autobio Diagnostics. Autobio’s SARS-CoV-2 rapid antibody test received EUA on April 24 for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human plasma from anticoagulated blood or serum. Authorization for the […]
FDA says Verathon recall of GlideScope Core smart cable is Class I
The FDA has declared the recall of a Verathon video laryngoscopy system is Class I, the most serious kind. Verathon’s GlideScope Core OneTouch smart cable is designed to offer views of the airway and vocal cords for medical procedures. The system’s Core OneTouch smart cable is used to connect the GlideScope spectrum single-use video laryngoscopes and […]
Zimmer Biomet recalls certain implants in Europe over toxin risk
Zimmer Biomet (NYSE:ZBH) has issued a recall for an unspecified number of polyethylene orthopedic implants in Europe due to the possible presence of elevated endotoxin levels. In a recall notice dated April 30, 2020, but published Thursday, the company said the issue was discovered during routine bacterial endotoxin testing of polyethylene implants. Three polyethylene implant samples […]
UK warns on spinal fixation system from Depuy Synthes
The United Kingdom issued a warning for failure in a spinal fixation system manufactured by Johnson & Johnson (NYSE:JNJ) unit DePuy Synthes. An alert sent out by the Medicines and Healthcare Products Regulatory Agency highlighted an issue with the cracking of the USS II Polyaxial 3D head rings that may result in the loosening of the spinal […]
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