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Advisory - Teleflex Medical Nasal Spray Syringe Devices Recalled; May Fail To Deliver Full Dose Of Medication



11/14/2016 10:06:06 AM

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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.


Read at BioSpace.com


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