Medline dialysis kits recalled over damaged Tego connector silicone seals
Medline is recalling certain Dialysis On/Off Kits containing Tego Connectors because the silicone seal may dome or tear, which can occlude the fluid path or allow leakage.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: this is an FDA Class II recall describing potential therapy interruption and contamination, with no hospitalisations stated in the source.
Plain-English summary
Medline Industries, LP is recalling Medline Dialysis On/Off Kits (SKU EBSI1746) containing Tego Connectors. About 2,020 units were distributed nationwide in the United States. The FDA has classified this recall as Class II.
Affected lots may exhibit issues with the silicone seal on the Tego Connectors, including 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, fluid leakage, interruption in therapy, exposure to biological contaminants, or air infused into the body.
Affected product carries UDI-DI 10653160373582 (each) and 00653160373585 (case), in kit lots 2024051380, 2024052080, 2024052180, 2024052280, 2024071580, 2025061790 and 2025072990.
Facilities can identify affected kits by the SKU, UDI and lot codes above, and may contact Medline Industries, LP for further information.
The recalled product
- Product
- Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Dialysis kit
- Affected units
- 2,020
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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