Advisory - Teleflex nasal spray syringe devices recalled; may fail to deliver full dose of medication

OTTAWA, Nov. 12, 2016 /CNW/ -

Issue
Health Canada is advising Canadians that the company Teleflex Medical is recalling certain lots of its "MAD Nasal™ Intranasal Mucosal Atomization Device" because they may not deliver a fully atomized (fine) spray of medication. This means patients may not receive the full dose, which could reduce the medication's effectiveness. The devices are used primarily by medically trained personnel but can also be used by first responders and the general public, such as parents and other caregivers.

The "MAD Nasal" device can deliver a range of medications in emergency and non-emergency situations, usually in cases where an alternative route of drug administration (such as intravenous injection) isn't ideal. In certain emergency situations, failure to deliver the full dose could lead to serious injury or death. These situations include the delivery of drugs used to:

• reverse life-threatening hypoglycemia (low blood sugar),
• treat epileptic seizures, or
• reverse life-threatening opioid overdose.

Who is affected

• Health care workers, paramedics, law enforcement officers, prison officers, fire fighters, and consumers, including parents and caregivers, who use or administer this medication-delivery device.

Affected product
The following lots are affected by the recall:

Code	Lot Number
MAD100	160105
	160137
	160302
	160402
	160435
	160506
	160523
	160609
	160620
MAD130	160138
MAD140	160125
	160218
	160437
	160610
MAD 300	160108
	160117
	160126
	160145
	160200
	160219
	160225
	160231
	160300
	160313
	160327
	160400
	160409
	160422
	160432
	160440
	160500
	160518
	160602
	160611
	160621
	160631
	160701
	160708
	160718
	160728

What consumers should do

• Stop using the affected product and return it to the place of purchase. Consumers can identify whether their product is affected by checking the packaging for the relevant lot number and product code. Each individual atomizer is packaged in a pouch. According to Teleflex, the lot number is listed on the pouch. Consumers who are unsure should contact the pharmacy or the company where it was purchased.
• Call 911 to seek medical help in an emergency situation, as medical personnel can deliver the needed medication using alternative methods of administration (e.g., via intravenous injection).
• Consult a healthcare professional for advice on alternatives, or if you have used or administered this product and have health concerns.
• Contact Teleflex Medical at 1-866-246-6990 if you have questions about this recall.
• Report adverse events to health products to Health Canada by calling toll-free at 1‑866‑234‑2345, or by reporting online, by mail or by fax.
• Report complaints about health products to Health Canada by calling toll-free at 1‑800‑267‑9675, or complete an online complaint form.

Background
These products can be used to spray medications directly into the nose for rapid absorption directly into the blood stream. The atomization device (cone shaped tip) is connected to a syringe.

Teleflex Medical has advised Health Canada that it has received complaints internationally that affected devices produce a straight stream of fluid rather than an atomised spray. No complaints have been reported in Canada. Approximately 30,240 units have been distributed in Canada.

Health Canada is aware of anecdotal reports of the Teleflex device being used off label in the United States to deliver the drug naloxone in the emergency treatment of known or suspected opioid overdose. It should be noted that another product also used for the emergency treatment of known or suspected opioid overdose, NARCAN® Nasal Spray, remains available in Canada and is not affected by this recall.

What Health Canada is doing
Health Canada will continue to monitor Teleflex Medical's recall and will inform Canadians if new safety information arises. Teleflex has committed to addressing the defect and to providing information to customers and the health system about unaffected, replacement devices, as these become available. 

Images
MAD Nasal^™ Intranasal Mucosal Atomization Device

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SOURCE Health Canada

PDF available at: http://stream1.newswire.ca/media/2016/11/11/20161111_C6581_PDF_EN_816845.pdf

For further information: Media Enquiries: Health Canada, [phone]; Public Enquiries: [phone], 1-866 225-0709