Recalls and Safety Alerts:
Covidien Oridion Labeled Capnostream 20 and Capnostream 20p Patient Monitor Battery Packs by Medtronic: Recall
Recall due to a battery manufacturing defect that may increase the risk of thermal damage in the battery pack…
Fetch 2 Aspiration Catheter by Boston Scientific: Recall
All reports of shaft breakage happened during the procedure, and the broken section was either removed while still partially attached to the catheter shaft or retrieved with a snare, without further patient complications…
All reports of shaft breakage happened during the procedure, and the broken section was either removed while still partially attached to the catheter shaft or retrieved with a snare, without further patient complications…
Focus Diagnostics Laboratory Examination Kits: Class I Recall
Recall due to poor lamination between the sample reaction wells which could lead to leakage into adjacent wells causing cross-contamination between samples, which could yield false positive, false negative, or invalid test results…
Recall due to poor lamination between the sample reaction wells which could lead to leakage into adjacent wells causing cross-contamination between samples, which could yield false positive, false negative, or invalid test results…
G4 Platinum and G5 Mobile Continuous Glucose Monitoring System Receivers by Dexcom: Class I Recall
The audible alarm may not activate in the receiver piece when low or high glucose levels are detected…
The audible alarm may not activate in the receiver piece when low or high glucose levels are detected…
Guardian II Hemostasis Valves by Vascular Solutions, Inc: Recall
The products have been recalled because they pose an increased risk of air leakage that may lead to an air embolism, which could result in serious injury or death…
The products have been recalled because they pose an increased risk of air leakage that may lead to an air embolism, which could result in serious injury or death…
Urogynecologic Surgical Mesh Implants by Boston Scientific: Notification
FDA is aware of allegations that Boston Scientific's urogynecologic surgical mesh may contain counterfeit raw material. We are examining these allegations to determine any necessary and appropriate next steps. FDA is not currently aware that the alleged counterfeit raw material contributes to adverse events associated with these products…
FDA is aware of allegations that Boston Scientific's urogynecologic surgical mesh may contain counterfeit raw material. We are examining these allegations to determine any necessary and appropriate next steps. FDA is not currently aware that the alleged counterfeit raw material contributes to adverse events associated with these products…
Interference between Computed Tomography (CT) and Electronic Medical Devices: Notification
FDA has received a small number of reports of adverse events that are believed to be associated with CT imaging of some implantable and wearable electronic devices…
FDA has received a small number of reports of adverse events that are believed to be associated with CT imaging of some implantable and wearable electronic devices…
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