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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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.
Affected kits may have silicone seal defects, including doming and tearing. These defects can lead to an occluded fluid path, preventing the withdrawal or injection of blood products.
There have been no specific incident or injury reports mentioned, but the potential for therapy interruption and exposure to biological contaminants exists.
Stop using these kits immediately and follow the recall instructions provided by Medline Industries. Contact your healthcare provider for further guidance.
For more information, contact Medline Industries at 1-800-633-5463 or visit their website for updates.
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