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Teleflex Medical recalls intranasal delivery device

According to numerous sources, Teleflex Medical has voluntarily recalled multiple lots of its LMA MAD intranasal delivery device because the devices are failing to aerosolize the drug.

The recall notification says, “Teleflex Medical is recalling these products as they may not deliver a fully atomized plume of medication. Teleflex Medical has received complaints that the affected lots produced a straight stream instead of an atomized spray. The failure of the device to deliver an atomized plume may impair the effectiveness of the medication with which it is used. This can lead to serious injury or death in certain emergency situations, such as where the device is used in an off-label manner for needle-free delivery of drugs for reversal of life threatening narcotic overdose, reversal of life threatening hypoglycemia, or treatment of epileptic seizures.”

The Teleflex device is used for delivery of Adapt Pharma’s intranasal naloxone, and a number of organizations have expressed concerns about a shortage of that product. According to the American Society of Health System Pharmacists, the company is unable to estimate a date for the release of replacement devices.

Read the Teleflex recall notification.

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published on November 7, 2016

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