Changeflow GovPing Healthcare Medline Dialysis Kit Recall - Silicone Seal Def...
Urgent Enforcement Removed Final

Medline Dialysis Kit Recall - Silicone Seal Defects

Favicon for changeflow.com FDA: Device Recalls Class II
Filed March 4th, 2026
Detected March 29th, 2026
Email

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

  1. Identify and quarantine affected Medline dialysis kits (SKU ECVC8415A, DT19810).
  2. Follow Medline's specific recall procedures for return or disposal.
  3. 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

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
FDA
Filed
March 4th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
Z-1465-2026

Who this affects

Applies to
Healthcare providers Medical device makers
Industry sector
3345 Medical Device Manufacturing 6211 Healthcare Providers
Activity scope
Medical Device Recalls Dialysis Maintenance
Threshold
Class II
Geographic scope
United States US

Taxonomy

Primary area
Product Safety
Operational domain
Compliance
Compliance frameworks
FDA 21 CFR Part 11
Topics
Healthcare Medical Devices

Get Healthcare alerts

Weekly digest. AI-summarized, no noise.

Free. Unsubscribe anytime.

Get alerts for this source

We'll email you when FDA: Device Recalls Class II publishes new changes.

Optional. Personalizes your daily digest.

Free. Unsubscribe anytime.