Medline dialysis maintenance kits recalled over Tego connector seal defects
Medline is recalling seven convenience kits used for dialysis maintenance because the silicone seal on the Tego Connectors may dome or tear, which can occlude the fluid path.
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 convenience kits used for dialysis maintenance, covering the Medline Add A Cath Dialysis Kit (SKU ECVC8415A), Centurion Central Line Insertion Tray (DT19810), Centurion Dialysis Bundle With No Catheter (CVI4310A), Medline Dialysis Cap Change Kit (DYNDC2425), Medline Dialysis Change Kit (EBSI1453A), Centurion Hemodialysis Access Kit (DT12970) and Medline Large Bore Dialysis Enhanced Securement kit (EBSI1741). About 14,525 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.
Each SKU carries its own UDI-DI and kit lot codes, listed in the FDA enforcement record.
Facilities can identify affected kits by the SKU, UDI and lot codes, and may contact Medline Industries, LP for further information.
The recalled product
- Product
- Convenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A Centurion CENTRAL LINE INSERTION TRAY SKU DT19810 Centurion DIALYSIS BUNDLE WITH NO CATHETTER SKU CVI4310A Medline DIALYSIS CAP CHANGE KIT SKU DYNDC2425 Medline…
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Dialysis kit
- Affected units
- 14,525
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- DIALYSIS
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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