Medline Industries recalled 14,525 dialysis convenience kits on January 8, 2026. The recall affects multiple product SKUs due to potential silicone seal failures. These issues may cause therapy delays or exposure to 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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These dialysis kits are used in medical settings for maintaining dialysis therapy. They are essential for patients undergoing hemodialysis and require reliable performance to ensure safety during treatment.
The silicone seals in the connectors may become damaged, leading to occlusions that prevent the proper flow of blood. This could result in delays of therapy or exposure to harmful contaminants.
This recall is not part of a broader industry pattern.
Patients and healthcare providers must stop using the affected kits immediately, which may cause interruptions in therapy and require sourcing alternative supplies.
The SKU and lot numbers can typically be found on the box or packaging of the dialysis kit.
Expect a refund or replacement process to take approximately 4-6 weeks after product return.
Keep records of your communication with the manufacturer, receipts of purchase, and any documentation related to the recall.
The recall includes Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A, Centurion CENTRAL LINE INSERTION TRAY SKU DT19810, and several other dialysis kits. These kits were distributed nationwide in the U.S.
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