Safety Report: Medline, LP Tracheostomy Care and Cleaning Trays - recalled due to Device & Drug Safety, USA

United States

Medline Industries, LP. announced a voluntary nationwide recall on October 10th, 2023, of several lots and SKUs of Tracheostomy Care and Cleaning Trays. The Tracheostomy Care and Cleaning Trays include a tracheostomy brush as a component that may have sharp edges at the tip that can puncture tubing during use and/or cause user injury during handling. The voluntary recall includes the following item numbers and lot numbers, distributed nationwide from March 21, 2022, through October 10, 2023. To date, Medline Industries, LP. has received one adverse event associated with this product.

In addition, complaints describe bristles of the tracheostomy brush detaching before and potentially during use. If bristles reach a patient’s airway, they may cause unexplained increases in sputum or pulmonary secretions, signs of infection, or difficulty breathing. If a patient exposed to the brush experiences any of these signs or symptoms, they should seek medical attention promptly.

Tracheostomy Care Trays are medical devices intended to be used for the care and maintenance of a stoma site. These trays may be used in various healthcare environments including acute care settings, such as hospitals, and long-term care settings such as skilled nursing facilities. The tracheostomy brush component is used to clean tracheostomy tubing and cannulas. Tracheostomy cannulas should always be rinsed following brush cleaning. This component is packaged within Tracheostomy Care and Cleaning Trays, which contain multiple components packaged together.

Affected product(s) can be identified by the lot number indicated on the medical device packaging. A list of the affected products is attached.

Medline Industries, LP. is implementing corrective and preventative actions. Medline Industries, LP. notified its distributors and consumers by First Class Mail and email on October 16, 2023, and instructed consumers to destroy and dispose of any affected product per local and state regulations. No product is to be returned to Medline Industries, LP. Any consumers or distributors that have a product that is being recalled should stop using the product and contact Medline Industries, LP.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Medline Industries, LP
Brand name: Medline
Product recalled: Tracheostomy Care and Cleaning Trays
Reason for the recall: Device & Drug Safety - Potential Component Defect
FDA Recall date: December 20, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/medline-industries-lp-issues-voluntary-nationwide-recall-various-lots-tracheostomy-care-and-cleaning