Recently, CNN reported that a recall has been issued for the Teleflex internasal mucosal atomizer. The recall involves the use of the atomizer to administer Naloxone, a drug used to treat opioid and heroin overdose. It is a voluntary recall issued by Teleflex, the company that manufactures the potentially defective medical devices.
What’s Wrong with the Teleflex Internasal Mucosal Atomizer?
Per the CNN report, Teleflex informed its distributors via a letter about the internasal mucosal atomizer recall. In the letter, the medical product manufacturer revealed that the devices may fail to administer a complete dose of Naloxone. The atomizer is supposed to deliver the medication as a spray, but the defect causes the drug to be administered as a stream. In such cases, the drug will not provide patients with the intended relief, because it does not cover enough surface area to be properly absorbed into the body, which greatly limits Naloxone’s effectiveness.
By late October, Teleflex had not received any reports of severe injuries or deaths related to the product defect. However, the manufacturer had learned of six related complaints. A University of Massachusetts professor of emergency medicine told CNN about witnessing several failures of the device firsthand. He told CNN he had suspicions that a problem with the devices could be behind the failure and emphasized that reversing heroin and opioid overdoses requires full doses of Naloxone.
In addition to notifying its distributors, Teleflex informed the US Food and Drug Administration (FDA) about the recall. Since using an internasal mucosal atomizer to deliver doses of Naloxone is considered an “off-label” use, Teleflex was not required to report adverse events related to using the atomizer to administer the drug to the FDA.
Why It’s Important Medical Product Companies Are Held Accountable
Anytime that a pharmaceutical product or medical device’s intended purpose is limited, it raises the chances that a patient could suffer a catastrophic injury or lose his or her life. That’s why it’s important that medical product companies are held accountable through product liability lawsuits. These suits encourage medical product makers to ensure that their drugs and devices do not pose a danger to the public if properly used. In addition, these claims enable injury victims and their families to get the help they need if they’re suffering because of a medical product company’s negligence.
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