FDA warns – Various lots of Medline Tracheostomy Care and Cleaning Trays recalled due to potential defect

Consumers and healthcare providers are advised that Medline Industries, LP. has voluntarily recalled multiple lots and SKUs of its Tracheostomy Care and Cleaning Trays because of a number of potential component defects.

According to the FDA, a tracheostomy brush included in the tray could have sharp edges at the tip, presenting a risk of puncture to tubing during use or injury to the handler. Other complaints point to the bristles of the tracheostomy brush coming apart before and possibly during use. In the event that bristles enter a patient’s airway, the patient may suffer “unexplained increases in sputum or pulmonary secretions, signs of infection, or difficulty breathing.” Anyone exhibiting these symptoms after being exposed to the brush are urged to seek immediate medical attention.

As multiple medical components packaged together to care for and maintain a stoma site, Tracheostomy Care Trays are implemented in different healthcare settings that include environments centered around acute care, like hospitals and long-term settings like skilled nursing facilities. After tracheostomy tubing and cannulas are cleaned with the tracheostomy brush component, tracheostomy cannulas should always be rinsed.

Initiated by Medline Industries, LP. on October 10, 2023, and updated on December 20, 2023, the voluntary recall covers trays under specific item numbers and lot numbers that were distributed across the U.S. between March 21, 2022 and October 10, 2023. To identify whether a given Tracheostomy Care and and Cleaning Tray is affected by the recall by locating the lot number on the device’s packaging.

Since the initial announcement, the company has made corrective actions and taken preventative measures. Distributors and consumers impacted by the recall were notified on October 16, 2023 by both First Class Mail and email. Users in possession of an affected tray were asked to cease all use and then to destroy and discard the item according to their local or state regulations.

At the time of the updated (December 20, 2023) FDA announcement, Medline Industries, LP. has been alerted to a single adverse event related to the problem.

Further questions about the recall can be directed to the company at 866-359-1704 or via email at recalls@medline.com. Representatives can be reached Monday through Friday, from 8:00 a.m. to 5:00 p.m. Central Time. Anyone experiencing health problems related to use of the product should consult their healthcare provider.

As the FDA continues to monitor the recall, the agency asks that all adverse reactions or quality issues be reported to its MedWatch program.


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