Merit Medical Systems, Inc.: Device Recall

Recall #Z-2566-2024 · 06/11/2024

Class II: Risk

Recall Details

Recall Number
Z-2566-2024
Classification
Class II
Product Type
Device
Recalling Firm
Merit Medical Systems, Inc.
Status
Ongoing
Date Initiated
06/11/2024
Location
South Jordan, UT, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
69 kits

Reason for Recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Product Description

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K11 (Custom Pressure Monitoring Kit), REF: K11-00382C To support fluid administration into the body and physiological pressure monitoring. To support various vascular or cardiac diagnostic and interventional procedures.

Distribution Pattern

U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

Other Recalls by Merit Medical Systems, Inc.

View all recalls by Merit Medical Systems, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.