Naloxone device recalled due to risk of serious injury, death

Naloxone device recalled due to risk of serious injury, death

(WTOL) - Teleflex Medical is recalling a naloxone nasal spray device due to a risk of serious injury, even death.

The Toledo-Lucas County Health Department held a press conference on the recall on Friday.

They stressed that the medication itself is not faulty but the atomizer device is.

"Your pushing too much pure liquid and not getting enough of those little droplets into the nose, into the nasal cavity to uptick into that individual," said Eric Zgodzinski.

The overdose reversal nasal atomizers were used in Project DAWN kits that have been distributed by the Health Department and that were assembled at the Ohio Pharmacy Service Center (OPSC).

Teleflex officials say 32 lot numbers sold after Jan. 1, 2016 may deliver a stream instead of an atomized spray, potentially making the overdose reversal drug less effective. The issue does not impact the medication itself, just the atomizer used to administer the drug.

The company included the following statement in the recall:

"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."

Although many Project DAWN kits distributed since then are anyone who has received one is asked to check the lot number on all atomizers.

The following lot numbers are listed in the product recall:

160108 160117 160126 160145 160146 160200 160219 160225
160231 160300 160313 160327 160400 160409 160422 160432
160440 160500 160518 160602 160611 160621 160631 160701
160708 160718 160728 160800 160804 160814 160816 160823

The health department says those impacted by the recall are spread out across the community.

Right now they are working on a kit exchange program.

"I want to urge everybody that once those kits are available, we need to get those others ones off of the streets and back to the actual supplier," said Zgodzinski.

The health department says despite the recall, they still stand by the product.

They are asking that any kits purchased from their pharmacy that match the recall be returned for replacement early next week.

A product exchange for kits obtained from Ohio Pharmacy Services will only be made for the lot numbers included in the list.

Customers who have recalled kits should return them to where they were originally purchased.

Although Teleflex Medical has not established a date when it will release a new product, alternative forms of naloxone may be available.

Anyone in need of a replacement should click here for a list of pharmacies that may have it in stock – People should also call the pharmacy to confirm the availability.

Please call the Ohio Department of Health's toll-free hotline at 1-844-364-4063 with questions about the recall.

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