Intranasal Naloxone Delivery System Recalled

Nov. 03--A manufacturer of a device used to administer naloxone, which can reverse the effects of an opiod overdose, is recalling the units.

Teleflex Medical Corp. issued the voluntary recall of its LMA MAD Intranasal Mucosal Atomization Device, warning that the hand-held device may not deliver the proper or effective dose of naloxone, which is known by the brand name Narcan.

Narcan and its generic form, according to the website drugs.com, "prevents or reverses the effects of opioids including respiratory depression, sedation and hypotension.''

The problem that led to Thursday's recall is with the delivery device, a syringe with a cone at the tip, not the drug itself, Connecticut state officials said. "It is supposed to deliver a plume or a puff of the drug up your sinuses,'' said Chris Stan, spokesman for the state Department of Public Health. "The defective ones deliver it in a stream instead of a plume.

"The state health department, Department of Consumer Protection and the Office of Emergency Medical Services (OEMS) are aware of the recall, and working together to determine if any of the affected products are in circulation with our emergency responders.''

To be properly absorbed through the nasal passages, naloxone must be delivered as a fine mist, according to an information sheet on the Teleflex website. The advantages to using the device instead of a syringe or intravenous line is that it is is quicker and reduces the chance that emergency workers can be injured by needles, Teleflex said.

The other ways to administer naloxone are more likely to be used by paramedics, a level of training and certification above emergency medical (EMS) technicians who are most often the first responders to a scene.

Connecticut law makes naloxone is available to customers through more than 300 participating pharmacies across the state, and other medical professionals, including dentists are allowed to prescribe it.

Stan of the state health department said the recall will not affect paramedic level organizations. "All patients will continue to receive appropriate pre-hospital emergency medical care in accordance with accepted standards of care,'' the health department spokesman said.

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