TOPIC: Various Lots of Tracheostomy Care and Cleaning Trays by Medline Industries: Recall - Due to Potential Component Defect
AUDIENCE: Patient, Health Professional, Risk Manager, Pulmonology
ISSUE: Medline Industries recalled several lots of Tracheostomy Care and Cleaning Trays on October 10, 2023. 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.
To date, Medline Industries has received one adverse event associated with this product.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: 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.
RECOMMENDATIONS:
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Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this medical device.
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Medline Industries 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.
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Any consumers or distributors that have product that is being recalled should stop using the product and contact Medline Industries.
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Consumers with questions regarding this recall can contact Medline Industries.
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