Md. health departments ready to assist residents with naloxone device recall Atomizer manufacturer finds specific lot numbers can provide insufficient dosages

Theo tin quận Montgomery

For Immediate Release: Friday, November 18, 2016 Baltimore, MD (November 18, 2016) – In response to Teleflex Medical Inc.’s medical device recall for specific lots of MAD Nasal Intranasal Mucosal Atomizer Device, the Department of Health and Mental Hygiene urges Marylanders who have received a naloxone kit to check their atomizer for recalled lot numbers. Teleflex received complaints that certain atomizers were delivering medication in a stream rather than a fully atomized plume. Although naloxone still will act to reverse an opioid overdose, defective devices may cause a risk of under-dosing of naloxone during nasal administration. The company issued the recall on October 27, 2016. Since then, Health and Mental Hygiene has conferred with local health departments to see if corresponding devices had been distributed through the Overdose Response Program. While it has been confirmed that some of the corresponding devices have been distributed, the department has not received any reports of product malfunctions. Members of the public who obtained naloxone kits with an atomizer delivery device in 2016 are encouraged to check their device for recall. There is a lot number on the plastic packaging of the atomizer. If the lot number on the atomizer matches one on the list below, you may contact your local health department for a replacement. Please note the recall is for the atomizer only and not naloxone. The medication should not be discarded. In response to rising overdose deaths, the State initiated the Overdose Response Program (ORP) in 2014 to provide overdose education and naloxone to the public. The ORP provides specialized, in-depth, hands-on training on opioid overdoses and naloxone administration. Since 2014, more than 60 local training programs have been authorized by Health and Mental Hygiene, including all local health departments and some law enforcement agencies, community-based programs and treatment agencies. In 2015, the department issued a standing order to allow pharmacists to dispense naloxone to ORP-certified individuals. To date, nearly 37,000 individuals have been trained in naloxone administration, and programs have provided more than 40,000 doses of naloxone at the time of training. For more information about naloxone, the Overdose Response Program, and contact information for your local health department, please visit https://goo.gl/JnVnyB. Health departments are also listed on our website at https://goo.gl/ekGg28. Teleflex Medical Inc. has issued a recall for the following lot numbers of MAD300 devices: 160108 160231 160440 160708 160117 160300 160500 160718 160126 160313 160518 160728 160145 160327 160602 160800 160146 160400 160611 160804 160200 160409 160621 160814 160219 160422 160631 160816 160225 160432 160701 160823 Marylanders who need help finding substance-use-disorder treatment resources should visit http://goo.gl/nIfGm0 or call the Maryland Crisis Hotline, which provides 24/7 support, at 1-800-422-0009. For information on many of the policies currently implemented to fight addiction and overdose in Maryland, see http://goo.gl/KvEzQw. If you know of someone in need of treatment for a substance use disorder, treatment facilities can be located by location and program characteristics on our page at http://goo.gl/rbGF6S. # # # The Maryland Department of Health and Mental Hygiene is the State agency that protects Maryland’s public health. We work together to promote and improve the health and safety of all Marylanders through disease prevention, access to care, quality management, and community engagement. Stay connected: www.twitter.com/MarylandDHMH and www.facebook.com/MarylandDHMH. ​ NOTICE: This message and the accompanying documents are intended only for the use of the individual or entity to which they are addressed and may contain information that is privileged, or exempt from disclosure under applicable law. If the reader of this email is not the intended recipient, you are hereby notified that you are strictly prohibited from reading, disseminating, distributing, or copying this communication. If you have received this email in error, please notify the sender immediately and destroy the original transmission. Release ID: 16-439 Media Contact: Mary Anderson 301-529-7669

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