Merit Medical Systems recalled 2,192 units of its Custom Manifold Kit on December 4, 2025. The inflation device handle may detach from the syringe during procedures. This poses a significant risk to patients and healthcare providers.
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 recalled product is the Custom Manifold Kit, REF: K09-13203A. It has been distributed worldwide, including all U.S. states and several international countries. Specific lot numbers include H2671718, H2681531, H2758436, H2792533, H2796074, H3046979, H3052442, H3147779, H3246149, H3254530, and H3297407.
The inflation device handle may detach from the syringe during procedures. This defect can lead to serious complications for patients undergoing medical treatments.
There are no specific incident reports mentioned, but the nature of the defect poses a high risk of injury. The recall is classified as Class II, indicating a potential for serious health consequences.
Patients and healthcare providers should immediately stop using the affected device. Contact Merit Medical Systems for further instructions on the recall and potential refunds.
For more information, contact Merit Medical Systems at the email provided in the recall notification.
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