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 Custom Manifold Kit is a medical device used in various healthcare procedures requiring syringe inflation. It is commonly utilized in environments like hospitals and clinics for patient care.
The inflation handle detachment poses a risk during medical procedures, potentially leading to complications or inadequate treatment.
This recall is not part of a broader industry pattern.
Patients and healthcare providers must act quickly to ensure safety and avoid complications during medical procedures.
Look for the REF number and lot numbers on the product packaging or accompanying documentation.
Expect refund processing to take approximately 4-8 weeks.
Keep records of your purchase, including receipts and any correspondence with the manufacturer.
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.
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