Modified: November 7, 2016 4:56pm
From the Office of the Commissioner of Health, Dr. Gale R. Burstein
November 7, 2016
CONTACT: Peter Anderson / Peter.Anderson@erie.gov
Phone: (716)858-8500 / Mobile: (716) 270-7842
BURSTEIN STATEMENT ON RECALL OF MAD300 MUCOSAL ATOMIZATION DEVICE FOR NALOXONE KIT
Potential Defect in Foam Atomizer for Naloxone Kits Spurs Recall of Devices; Medication Contained inside is still Viable, Effective
ERIE COUNTY, NY— 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 Erie County Department of Health and its community partners, has issued a recall notification.
Recall information regarding specific atomizer batch and lot numbers is available at www.erie.gov/health.
“Erie County first responders and residents who may possess the affected product should understand that the naloxone medication in the kits remains safe and effective,” explains Erie County Health Commissioner Dr. Gale Burstein. “Only the foam atomizer was recalled because of a potential defect.”
Dr. Burstein urges those who may be in possession of the defective naloxone atomizers to avoid discarding the naloxone medication. Burstein added, “The naloxone medication can save lives.”
The Teleflex recall identifies specific lot numbers of affected MAD300 mucosal atomization devices. The affected product began shipping from Teleflex 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—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.
Dr. Burstein emphasizes that naloxone still can save lives. Burstein said, “Until the atomizers can be replaced by the manufacturer, please continue to use. However, the user should be aware that the medication distribution may not be as well dispersed and work as efficiently as intended.”
Options are available to replace the atomizers, including purchasing them at a local pharmacy if they are available in stock. Most mucosal atomizers cost less than $10. Another option is rectal delivery of the naloxone medication with the atomizer. Rectal administration using an atomizer does not require an even mist generated to effectively deliver the medication.
The NYSDOH AIDS Institute is evaluating the situation and will provide additional information. Please send questions to firstname.lastname@example.org.
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