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

Starting date:
November 12, 2016
Type of communication:
Advisory
Subcategory:
Medical Device
Source of recall:
Health Canada
Issue:
Product withdrawal, Dosage
Audience:
Healthcare Professionals, General Public
Identification number:
RA-61008

Update – December 08, 2016

On November 12, 2016, Teleflex Medical recalled certain lots of its “MAD Nasal™ Intranasal Mucosal Atomization Device” because these devices 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 company has indicated that some customers, because of medical necessity, plan to continue using the affected lots rather than return them. Teleflex is advising those customers to pre-test each unit to determine whether it is defective by following the instructions for continued use of recalled lots. Those instructions are provided below. Health Canada and Teleflex continue to advise all other customers to follow the instructions provided in the original November 12, 2016 advisory further below (see the “What consumers should do” section).

Instructions for continued use of recalled lots

Test affected devices before use by following these steps:

  • Attach a syringe containing 1mL of either sterile water or sterile saline to the device.
  • Briskly compress the plunger on the syringe so as to deliver the liquid through the device and observe how the liquid comes out at the [distal] end.
  • If the liquid sprays in a fine mist, then the device is atomizing as intended.
  • If the device produces a straight stream, return it to the place of purchase. If you have multiple devices, select another for testing and use.

Note: This pre‐test is not required for lots not affected by this recall.

Original Advisory - 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.

Products affected

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;60117;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 you 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.

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.

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.

Media enquiries

Health Canada
(613) 957-2983

 

Public enquiries

(613) 957-2991
1-866 225-0709

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.

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