Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548, K09-14000A, K09T-12020D, K09T-12275B
Reported: August 20, 2025 Initiated: June 5, 2025 #Z-2295-2025
Product Description
Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548, K09-14000A, K09T-12020D, K09T-12275B
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.
Details
- Recalling Firm
- Merit Medical Systems, Inc.
- Units Affected
- 6327
- Distribution
- 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.
- Location
- South Jordan, UT
Frequently Asked Questions
What product was recalled? ▼
Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548, K09-14000A, K09T-12020D, K09T-12275B. Recalled by Merit Medical Systems, Inc.. Units affected: 6327.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 20, 2025. Severity: Moderate. Recall number: Z-2295-2025.
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