Recalls and Safety Alerts:
Big Sky Diagnostic Imaging, LLC: FDA Safety Communication
Results from a review included poor quality mammograms, this does not mean that the results of the examinations were inaccurate but patients should speak to their health care providers about whether their mammograms need to be repeated…
ConvaTec, Inc., Flexi-Seal CONTROL Fecal Management System Kit: Class I Recall
No 510k application was submitted to FDA for this device…
HydroFinity Hydrophilic Guidewires by NDC/Covidien: Recall
The outer polymer jacket to the core wire may be damaged or torn during use, such as when the guidewire is withdrawn quickly through certain delivery catheters. ..
Smiths Medical Portex Low Dead Space Connector with Sideport, 3.5mm: Class I Recall
One lot of 3.0mm sized connectors were mislabeled in packages as 3.5mm…
Advocate Redi-Code+ Blood Glucose Test Strips by Diabetic Supply of Suncoast: Recall
Labeling error could result in confusion about which meter models the Redi-Code+ BMB-BA006A blood glucose test strips are designed to be used with…
Discussions with Healthcare Providers:
Ortho-phthalaldehyde (OPA): Small Sample Survey Summary
The purpose of this survey is to enhance FDA’s understanding of clinicians' perspectives on ortho-phthalaldehyde (OPA)…
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