DPH: Voluntary Recall Notice Announced on Medical Device Commonly Used to Deliver Overdose Reversal Medicine

Voluntary Recall Notice Announced on Medical Device Commonly Used to Deliver Overdose Reversal Medicine

Teleflex Medical has issued a voluntary recall of LMA MAD Intranasal Mucosal Atomization Device. This device is commonly used to deliver naloxone, a life-saving drug used in the event of a suspected drug overdose. The device is also used to administer medication for life-threatening hypoglycemia and epileptic seizures.

The affected devices may not deliver a fully atomized plume of medication and, as a result, possibly impair the efficacy of the product when used in emergency overdose situations. It should be noted that this is a delivery device issue, and not a problem with the drugs that are being administered.

The Department of Consumer Protection, the Department of Public Health, Office of Emergency Medical Services (OEMS) are aware of the recall, and working together to determine if any of the affected products are in circulation with our emergency responders.

This recall may result in a shortage of Naloxone to some basic life support Emergency Medical Services (EMS) organizations. This recall will not affect paramedic level organizations. All patients will continue to receive appropriate pre-hospital emergency medical care in accordance with accepted standards of care.

In Connecticut, naloxone is available to customers through certified pharmacists at over 300 participating pharmacies across the state. In addition to certified pharmacists, Connecticut law allows other prescribers, including physicians, surgeons, Physician Assistants (PAs), Advanced Practice Registered Nurses (APRNs), and dentists to prescribe, dispense and/or administer the medication.

For information on which product codes and lot numbers have been recalled, please visit: http://www.ct.gov/dmhas/lib/dmhas/newsworthy/mad_recall.pdf

For the Department of Consumer Protection’s interactive map of participating pharmacies, refer to: http://www.ct.gov/dcp/cwp/view.asp?a=1620&q=581898





Content Last Modified on 11/3/2016 12:03:02 PM