Thursday, November 17, 2016
(Liberty, 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, has notified all first responders, health care professionals and others who have received kits through naloxone training programs, may be affected by the recall and to check the lot numbers of the atomizers in their naloxone kits.
Recall information regarding specific atomizer batch and lot numbers is available on the website of Public Health Services by going to www.co.sullivan.ny.us/ and clicking on the tabs for Departments / Public Health Services.
“Sullivan 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 Sullivan County Director of Public Health, Nancy McGraw. Only the foam atomizer device was recalled because of a potential defect which may result in the medication being dispersed in a straight stream instead of atomized mist.
McGraw 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,” McGraw said. “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. “However, there is a possibility of under-dosing with naloxone while administering it to someone who has overdosed on opioids, and additional administration with a second kit may be necessary” because of the increasing risk of more potent illicit drugs on the street, including fentanyl, according to officials at the NYS Department of Health.”
The Teleflex recall identifies specific lot numbers of affected MAD300 mucosal atomization devices. Not all devices shipped by Teleflex are impacted by the recall notice - only those with matching lot numbers. Sullivan County Public Health Services’ registered naloxone training program has been working with its Medical Director, and public health staff have contacted all first responders and individuals who have been trained by its program and has determined that some of the kits are affected.
For individuals in the community who have been trained by and received kits from other community organizations, 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. Send questions to email@example.com. First responders and others who have received training through Sullivan County Public Health’s registered naloxone training program who have questions should call our EPI department at (845) 292-5910.