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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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.
The Tego Connectors in these kits may have defective silicone seals that can tear or dome. This can lead to an occluded fluid path, delay in therapy, and exposure to biological contaminants.
No specific injuries or incidents have been reported. However, the potential for severe consequences exists due to therapy interruptions.
Stop using the affected medical kits immediately. Contact Medline Industries or your healthcare provider for instructions on returning the product.
For further information, reach out to Medline Industries, LP at their official website or contact your healthcare provider.
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