Class II — Potential Health Hazard

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

6IN PRESSURE TUBING Recalled by Smiths Medical Asd Inc Due to There is a manufacturing defect affecting specific rotator...

Date: November 10, 2023
Company: Smiths Medical Asd Inc
Status: Ongoing
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 Smiths Medical Asd Inc directly.

Affected Products

6IN PRESSURE TUBING, List Number MX20617

Quantity: 31,685 total

Why Was This Recalled?

There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Smiths Medical Asd Inc

Smiths Medical Asd Inc has 10 total recalls tracked by RecallDetector.

Related Recalls

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