Medline Dialysis Kit Recall - Silicone Seal Defects
Summary
The FDA has initiated a Class II recall for Medline dialysis kits due to defects in the silicone seal of Tego Connectors. These defects can lead to occluded fluid paths, potentially impacting the ability to inject or withdraw blood products. The recall affects nationwide distribution in the US.
What changed
The FDA has classified a recall of Medline Industries, LP dialysis kits as Class II due to defects in the silicone seal of Tego Connectors. The defects include doming and tearing of the seal, which can result in an occluded fluid path, preventing users from injecting or withdrawing blood products with a syringe. This poses a risk to patient safety during dialysis maintenance.
Healthcare providers and medical device distributors nationwide are affected by this recall. Affected parties should identify and quarantine the specified Medline ADD A CATH DIALYSIS KIT (SKU ECVC8415A), Centurion CENTRAL LINE INSERTION TRAY (SKU DT19810), and Centurion DIALYSIS BUNDLE WITH NO CATHETTER. While the document indicates the recall is ongoing, specific instructions for return or disposal should be followed as per Medline's recall procedures to mitigate patient risk.
What to do next
- Identify and quarantine affected Medline dialysis kits (SKU ECVC8415A, DT19810).
- Follow Medline's specific recall procedures for return or disposal.
- Review internal inventory and patient usage logs for affected kits.
Source document (simplified)
Medline Industries, LP
Device Recalls (Class II)
← All Device Recalls (Class II) Class II Z-1465-2026 · 20260304 · Ongoing
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...
Reason for Recall
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....
Distribution
US Nationwide distribution.
Source: openFDA Enforcement API
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