Medline Industries recalled 150 dialysis convenience kits on January 8, 2026, due to silicone seal defects. Affected kits may obstruct fluid paths and risk exposure to biological contaminants.
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
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 dialysis convenience kits are used in medical settings for blood product management in patients undergoing dialysis. They are essential for ensuring the safe delivery and withdrawal of blood products during treatment.
The silicone seal defects can cause blockages in fluid paths, meaning healthcare providers may not be able to inject or withdraw necessary blood products, leading to critical delays in patient care.
This recall is not part of a broader industry pattern.
Patients and providers need to stop using these kits immediately due to potential health risks. The risk of exposure to contaminants or interrupted therapy creates urgency for action.
The SKU and lot numbers are typically printed on the product packaging or accompanying documentation.
Expect a refund or replacement process to take approximately 4-6 weeks.
Keep records of all communications with Medline and any documentation related to the recall, including receipts and product photos.
The recall involves convenience kits containing Tego Connectors, specifically SKU DYNDC3167. The affected lots are 24IME953 and 25CMA708, distributed nationwide.
Not sure what to do next? Our guide walks you through the process step by step.
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