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Health Canada Health products

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

Issued November 12, 2016
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.
Hazard description
Dosage
What to 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 .