Medline Industries recalled 516 medical kits on January 8, 2026, due to issues with Tego Connectors. The silicone seal may tear or dome, posing a high risk of therapy interruption and exposure to contaminants. Healthcare providers must stop using these devices immediately and follow recall instructions.
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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Medline medical kits are used in various healthcare settings for procedures involving fluid management. They are essential for safe and effective medical treatments, making them critical for healthcare providers.
The defect in the silicone seal can lead to a blockage in the fluid pathway, which can interrupt treatment and expose patients to potential contaminants or air. This can have serious implications for patient safety.
This recall is not part of a broader industry pattern.
Consumers may face delays in critical medical treatments due to the potential hazards associated with these kits. Immediate action is necessary to prevent health risks.
SKU and lot numbers can typically be found on the product packaging or accompanying documentation.
Expect a refund or replacement to be processed within 4 to 6 weeks after returning the product.
Keep all receipts, correspondence with Medline, and photos of the affected product for your records.
The recall affects Medline IR Pack (SKU DYNJ67205C) and Medline NO CATHETER DIALYSIS INSERTION (SKU CVI5200). These kits were distributed nationwide in the United States.
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