Class II — Potential Health Hazard

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

Midline Catheter Dressing Change Kit with Statlock - Product Usage: Recalled by Trinity Sterile, Inc. Due to Evidence of face masks or other material in...

Date: February 23, 2021
Company: Trinity Sterile, Inc.
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 Trinity Sterile, Inc. directly.

Affected Products

Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). Product Number: TRIO0000l

Quantity: 2970 units

Why Was This Recalled?

Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Trinity Sterile, Inc.

Trinity Sterile, Inc. has 10 total recalls tracked by RecallDetector.

Related Recalls

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