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 Medline Dialysis On/Off Kit is designed to assist healthcare providers in administering dialysis treatment to patients. These kits are critical for ensuring safe and effective blood product management during dialysis procedures.
Defective silicone seals on the Tego Connectors can lead to fluid leakage or air exposure during dialysis, which may compromise patient safety. This defect can interrupt therapy and delay necessary treatments.
This recall is not part of a broader industry pattern.
Patients relying on these dialysis kits face potential interruptions in therapy and exposure to health risks, highlighting the urgency for immediate cessation of use.
Lot numbers and SKU can typically be found on the packaging of the dialysis kit or on the product label.
Expect a refund or replacement to be processed within 4-6 weeks after returning the product.
Keep all receipts, correspondence with the manufacturer, and photos of the product as evidence.
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.
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