Merit Medical Systems recalled 864 units of its Custom Waste Management Kit Vascular Tray on December 4, 2025. The handle of the inflation device may detach from the syringe during use, posing a serious risk to patients. Healthcare providers should stop using the device immediately and follow recall instructions.
Inflation device handle may detach from the syringe during procedure.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Merit Medical Systems, Inc. or your healthcare provider for instructions. Notification method: E-Mail
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The Custom Waste Management Kit Vascular Tray is used in medical procedures to manage waste safely. Healthcare providers rely on this device to ensure proper handling during vascular interventions.
The inflation device's handle detaching from the syringe can interrupt procedures, leading to potential complications and risks for patients.
This recall is not part of a broader industry pattern.
Patients and healthcare providers must act promptly to avoid complications from using the recalled device.
The model number and UDI can typically be found on the product label or packaging.
Expect a refund or replacement process to take approximately 4-6 weeks.
Document all correspondence regarding the recall and keep any packaging or labels as evidence.
The recalled product is the Custom Waste Management Kit Vascular Tray, REF: K10T-05261. It was distributed worldwide, including all U.S. states and several countries. The model is identified by UDI: 00884450320297.
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