Medline Industries recalled over 926,000 IV Administration and Extension Sets due to a significant risk of leaks and breaks. The recall affects multiple models with potential exposure to chemicals and mechanical forces. Users should discontinue use immediately to prevent serious health risks including blood loss and infections.
Under circumstances involving exposure to particular chemicals and mechanical forces, the male luer connectors for the specified IV Administration and Extension sets may leak, crack, and/or break during use, which may result in a delay in patient treatment, blood loss, infection, an air embolism, and/or underdosage of medication.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Letter
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The recall encompasses 23 models of IV Administration and Extension Sets, including model numbers DYNDTB0529, DYNDTB1029, and DYNDTB1516. These products were distributed worldwide, including throughout the United States and the Bahamas. The products were sold from various healthcare suppliers.
The male luer connectors on these IV sets may leak, crack, or break when exposed to certain chemicals and mechanical forces. This defect could delay patient treatment, lead to blood loss, cause infections, produce air embolisms, and result in underdosage of medication.
The recall is classified as Class II due to the high risk associated with the potential failures of these devices. No specific injury or incident counts are reported, but the hazards pose serious health risks.
Patients and healthcare providers should stop using the recalled IV sets immediately. They should follow the recall instructions provided by Medline Industries and contact the company for further guidance on returns and refunds.
For more information, contact Medline Industries at 1-800-633-5463 or visit their website. Further details can be found on the FDA's website regarding the recall.
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