- Recall notice, lot numbers and additional details
- Press Release: 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
Teleflex Medical, the manufacturer of the MAD300 mucosal atomization device used by opioid overdose prevention programs across New York State, has issued the attached recall notification. Recall information is also attached from McKesson Medical-Surgical (MMS), a pharmaceutical distributor.
The Teleflex recall identifies specific lot numbers of affected MAD300 devices. It also provides instruction to discontinue use of affected product and to quarantine your current inventory for affected lots. Teleflex has confirmed that 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.
It is very important that you check the lot numbers on the MAD300 device cartons in your inventory and follow the instructions in the attached recall notices. A pharmaceutical distributor (either MMS or Cardinal) will contact you regarding how to handle any product you have quarantined.
Teleflex may have difficulty satisfying the demand for its MAD300 device in the near future. The Department is working diligently to ensure that you receive naloxone as expeditiously as possible. The NYSDOH AIDS Institute is evaluating these events and will provide additional information. Please send any questions to firstname.lastname@example.org.