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Posted on: November 9, 2016

RECALL OF ATOMIZATION DEVICE FOR NALOXONE (NARCAN) KIT

MDA300 naloxone atomizer recall

Medication Contained inside is still Viable, Effective despite Potential Defect in Foam Atomizer for Naloxone Kits

MAYVILLE, N.Y.:— Teleflex Medical, the manufacturer of the MAD300 mucosal atomization device used as part of the naloxone (e.g., “narcan”) delivery system by opioid overdose prevention programs across New York State, including the Chautauqua County Department of Health and Human Services (CCDHHS) and its community partners, has issued a recall notification.

Recall information regarding specific atomizer batch and lot numbers is available on the CCDHHS website at www.co.chautauqua.ny.us/802/Recall-Notice .

“Chautauqua County first responders and residents who may possess the effected product should understand that the naloxone medication in the kits is safe and effective,” said Chautauqua County Director of Health and Human Services Christine Schuyler. “Only the foam atomizer was recalled because of a potential defect which may result in the medication being dispersed in a straight stream instead of atomized mist.”

Schuyler urges those who may be in possession of the defective naloxone atomizers to NOT discard the naloxone medication.

“The naloxone medication can save lives; please continue to use the atomizers in the existing kits until it can be replaced by the manufacturer,” said Schuyler. “While the medication may not come out as well dispersed and work as efficiently as it is intended to, it can still work to reverse an overdose.”

The Teleflex recall identifies specific lot numbers of affected MAD300 mucosal atomization devices. The effected product began shipping from Teleflex on January 1, 2016 and was discontinued on October 6, 2016. Not all devices shipped during this period are impacted by the recall notice—only those with matching lot numbers.

It is very important to check the lot numbers on the MAD300 mucosal atomization device cartons and follow the instructions in the attached recall notices.

Teleflex may have difficulty satisfying the demand for its MAD300 mucosal atomization device in the near future. Another option available to replace the atomizers is to purchase them at a local pharmacy if they are available in stock. Most atomizers cost less than $10.

The NYSDOH AIDS Institute is evaluating the situation and will provide additional information. Please send questions to overdose@health.ny.gov.

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