Medline Industries is voluntarily recalling several lots and SKUs of tracheostomy care and cleaning trays, according to a safety communication from the US Food and Drug Administration.
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.
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.
Medline Industries has received one adverse event associated with this product.
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.
The voluntary recall includes certain item numbers and lot numbers, distributed nationwide from March 21, 2022, through Oct 10. Affected products can be identified by the lot number indicated on the medical device packaging.
Medline Industries is implementing corrective and preventative actions, according to the safety communication. Medline Industries notified its distributors and consumers by First Class Mail and email on Oct 16 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. Any consumers or distributors that have a product that is being recalled should stop using the product and contact Medline Industries.
Consumers with questions regarding this recall can contact Medline Industries by phone at 866-359-1704 or [email protected] Monday through Friday between 8 am and 5 pm CST.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
The recall is being conducted with the knowledge of the US Food and Drug Administration.
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