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April 27, 2016
Fresenius Kabi USA is voluntarily recalling 30 mL vials of Sensorcaine®-MPF (bupivacaine HCl). One lot (Lot Number 6111504; Product Code 470237) was found to have visible particulate matter that the company believes is glass.
Sensorcaine®-MPF injections are used as local or regional anesthesia/analgesia for dental, oral surgery, as well as therapeutic, diagnostic, and obstetric procedures.
The company warns that administering a solution containing glass particulates may result in "inflammation or injury," although, there have been no reports of adverse events. Professionals are encouraged to contact the company with any questions and patients should contact their physician should they experience any problems.
More information on the FDA MedWatch recall announcement can be found here.
April 1, 2016
A small number of reports have been received by the FDA regarding “adverse effects” thought to be associated with CT imaging of wearable and implantable medical devices such as neurostimulators, insulin pumps, and cardiac implanted devices.
If the CT scanner irradiates the circuitry of certain devices it can cause enough interference to affect the operation of the device. However, the likelihood of that happening is very low and the FDA believes that the benefit of CT scanning greatly outweighs the odds of such an event.
Professionals and patients are asked to complete and submit a report of any side effects. To learn more, please read the FDA’s safety alert: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm493739.htm
March 23, 2016
There are so many exam gloves to choose from. However, powdered gloves might not be around too much longer. The FDA recently published the article: Proposal to Ban Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove.
They are finding issues caused by the powder on the gloves and are causing serious injury to patient's. Risks include: respiratory allergic reactions, lung inflammation, post-surgical adhesions, & possible death. The FDA doesn't think updated or new labels on gloves will correct the issue and powdered gloves are avoidable.
See more information on the FDA's website.