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Device used to administer naloxone recalled

Officials warned that the handheld device, a nasal syringe, may not deliver the proper or effective dose of naloxone

By Frank Juliano
Connecticut Post

MORRISVILLE, N.C. — A manufacturer of a device used to administer a drug that can reverse the effects of an opioid overdose — is recalling the units, and state officials said Thursday the move may cause a shortage of the life-saving drug among first responders.

Teleflex Medical Corp. issued the voluntary recall of its MAD Nasal Intranasal Mucosal Atomization Device, warning the hand-held device, a nasal syringe, may not deliver the proper or effective dose of naloxone hydrochloride.

Police in Seymour, Trumbull and Monroe carry the drug, and officers in each town have been credited with saving at least one life by administering naloxone hydrochloride. West Haven police saved five lives in one night last month by administering the drug.

Generic naxolone, and brand-name forms of the drug including Evzio and Narcan, “prevents or reverses the effects of opioids, including respiratory depression, sedation and hypotension,” according to the website drugs.com.

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, 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 web site. 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.

Bridgeport firefighters carry a red pouch with two doses of naloxone hydrochloride, one in a syringe and another in an inhaler, along with alcohol wipes and gloves. The department recently received 400 doses of the life-saving antidote. Chief Richard Thode said that Bridgeport firefighters administer the drug an average of twice a day to bring overdose victims back from the brink of death.

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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