Medline Industries recalled 2,020 dialysis kits on January 8, 2026, due to defective silicone seals. The seals may dome or tear, leading to fluid leaks and contamination. Patients and healthcare providers should stop using these kits immediately.
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 involves Medline Dialysis On/Off Kits, SKU EBSI1746, including Tego Connectors. The affected lots are 2024051380, 2024052080, 2024052180, 2024052280, 2024071580, 2025061790, and 2025072990. These kits were distributed nationwide in the United States.
The silicone seals on the Tego Connectors may exhibit doming or tearing. This defect can obstruct the fluid path, preventing users from injecting or withdrawing blood products. Such failures can delay therapy and expose patients to biological contaminants or air.
No specific incidents or injuries have been reported related to this recall. The potential risks include delays in therapy and exposure to contaminants.
Patients and healthcare providers must stop using the affected dialysis kits immediately. Follow the recall instructions provided by Medline. Contact Medline Industries or your healthcare provider for further instructions.
For more information, call Medline Industries at 1-800-396-2020 or visit their website at www.medline.com.
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