Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP
FDA Recall Z-2296-2025 · Posted 2025-08-12
Recalling FirmMerit Medical Systems, Inc.
Recall StatusOpen, Classified
Product CodePPD
Date Initiated2025-06-05
Product Quantity858
Reason for Recall
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.
Firm Action
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 [email protected]
If you have questions, contact the firm's customer service at [email protected] or via phone at +1 800 356 3748, Hours: 6 am to 6 pm MST, Mon-Fri
Root Cause
Process control
Distribution Pattern
US Nationwide distribution in the states of OH, CA, SD, VA, AZ, MT, TX, MI, FL, TN, PA, NJ, MN, ND, IA, LA, UT, KY, IL, OK, ME, IN, NY, NM, SC, AL, ID, CT, WI, GA, MA, NC, AR, WA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.