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