Custom Waste Management Kit (Merit Medical) – Air Trapping Risk (2025)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.

Recommended Action

Per FDA guidance

On 5/5/2025, recall notices were emailed to customers who were asked to do the following: 1) Identify affected devices and quarantine, discontinue use and distribution. Ensure that applicable personnel within your organization are made aware of this field action. 3. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the customer response form. 4. Return all affected devices to the firm. 5. Complete, and return the customer response form via email to response@merit.com If you have questions, contact the firm's customer service at RESPONSE@merit.com or via phone at +1 800 356 3748, Hours: 6 am to 6 pm MST, Mon-Fri