Reported Mar 4, 2026 · Ongoing
Convenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A Centurion CENTRAL LINE…
Medline Industries, LP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medline Industries, LP · 3 Lakes Dr · Northfield, IL · 60093-2753
Is this the product you have?
8 of 8 products
| Model / number | Barcodes | Product as published |
|---|---|---|
ECVC8415A | 1065316038362800653160383621 | UDI-DI (ea) 10653160383628 UDI-DI (case) 00653160383621 Kit lots 2024121390 2025033190 Centurion CENTRAL LINE INSERTION TRAY |
DT19810 | 1065316036875500653160368758 | UDI-DI (ea) 10653160368755 UDI-DI (case) 00653160368758 Kit |
| — | lot 2025041090 Centurion DIALYSIS BUNDLE WITH NO CATHETTER | |
CVI4310A | 1065316037497800653160374971 | UDI-DI (ea) 10653160374978 UDI-DI (case) 00653160374971 Kit lots 2024051490 2025021290 2025051390 2025091090 Medline DIALYSIS CAP CHANGE KIT |
DYNDC2425 | 1065316037584500653160375848 | UDI-DI (ea) 10653160375845 UDI-DI (case) 00653160375848 Kit lots 2024060690 2024101690 2024103190 2025010890 2025040190 Medline DIALYSIS CHANGE KIT |
EBSI1453A | 1065316038347500653160383478 | UDI-DI (ea) 10653160383475 UDI-DI (case) 00653160383478 Kit lots 2024050790 2024051390 2024082290 2024111990 2025013090 2025032090 2025050190 2025062790 Centurion HEMODIALYSIS ACCESS KIT |
DT12970 | 1065316036892200653160368925 | UDI-DI (ea) 10653160368922 UDI-DI (case) 00653160368925 Kit lots 2025040401 2025081401 Medline LARGE BORE, DIALYSIS, ENHANCED SECUREMENT |
EBSI1741 | 1065316037452700653160374520 | UDI-DI (ea) 10653160374527 UDI-DI (case) 00653160374520 Kit lots 2024061780 2024070180 2024081280 2024111290 2025012490 2025032690 2025051390 2025061790 2025071490 2025072190 |
- Amount recalled
- 14,525
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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