Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Medcomp Duo-Flow 400XL Catheter Recalled by Medical Components, Inc dba MedComp Due to Medcomp has initiated the recall of Duo-Flow 400XL...

Date: February 5, 2015
Company: Medical Components, Inc dba MedComp
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Medical Components, Inc dba MedComp directly.

Affected Products

Medcomp Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III; AngioDynamics product- Dura-Flow Catheter, Schon XL Catheter; The affected product are insertion kits used to implant the devices packaged-long and short term hemodialysis catheters and infusion catheters.

Quantity: 3152

Why Was This Recalled?

Medcomp has initiated the recall of Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III because the product shipped was out of specification. One BI (biological indicator) out of 21 on the sterilization load was out of specification.

Where Was This Sold?

Worldwide Distribution.

About Medical Components, Inc dba MedComp

Medical Components, Inc dba MedComp has 38 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report