Medline Industries is voluntarily recalling a number of heaps and SKUs of tracheostomy care and cleansing trays, in keeping with a security communication from the US Meals and Drug Administration.
The tracheostomy care and cleansing trays embrace a tracheostomy brush as a element that will have sharp edges on the tip that may puncture tubing throughout use and/or trigger consumer harm throughout dealing with.
As well as, complaints describe bristles of the tracheostomy brush detaching earlier than and probably throughout use. If bristles attain a affected person’s airway, they might trigger unexplained will increase in sputum or pulmonary secretions, indicators of an infection, or issue respiration. If a affected person uncovered to the comb experiences any of those indicators or signs, they need to search medical consideration promptly.
Medline Industries has acquired one hostile occasion related to this product.
Tracheostomy care trays are medical units meant for use for the care and upkeep of a stoma web site. These trays could also be utilized in numerous healthcare environments together with acute care settings, similar to hospitals, and long-term care settings similar to expert nursing amenities.
The tracheostomy brush element is used to wash tracheostomy tubing and cannulas. Tracheostomy cannulas ought to at all times be rinsed following brush cleansing. This element is packaged inside tracheostomy care and cleansing trays, which include a number of elements packaged collectively.
The voluntary recall contains sure merchandise numbers and lot numbers, distributed nationwide from March 21, 2022, by Oct 10. Affected merchandise will be recognized by the lot quantity indicated on the medical machine packaging.
Medline Industries is implementing corrective and preventative actions, in keeping with the protection communication. Medline Industries notified its distributors and customers by First Class Mail and e mail on Oct 16 and instructed customers to destroy and eliminate any affected product per native and state laws. No product is to be returned to Medline Industries. Any customers or distributors which have a product that’s being recalled ought to cease utilizing the product and make contact with Medline Industries.
Customers with questions concerning this recall can contact Medline Industries by cellphone at 866-359-1704 or [email protected] Monday by Friday between 8 am and 5 pm CST.
Adversarial reactions or high quality issues skilled with using this product could also be reported to the FDA’s MedWatch Adversarial Occasion Reporting program both on-line, by common mail, or by fax.
The recall is being carried out with the information of the US Meals and Drug Administration.
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