Class 2 Device Recall Merit Medical

• Date Initiated by Firm: June 11, 2024
• Date Posted: August 12, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2569-2024
• Recall Event ID: 94797
• Product Classification: Fluid drainage tray - Product Code PXU
• Product: Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: PC (Pericardiocentesis Tray - Fluid drainage tray), REF: PC101/B PC801 PC801/A PC802 PC802/A The Pericardiocentesis Kit is intended to withdraw fluid from the pericardial sac (membrane surrounding the heart) to evaluate the fluid for diagnostic purposes or to remove excess fluid causing compression of the heart.
• Code Information: Catalog Number/UDI-DI code/Lot Numbers: PC101/B 00884450015278 T2158130 T2169450 T2199673 T2208910 T2223544 T2232658 T2241254 T2246241 T2248296 T2269052 T2278244 T2298721 T2299544 T2303828 T2303868 T2303870 T2312911 T2315079 T2329632 T2340038 T2351178 T2366374 T2382095 T2382096 T2398873 T2403711 T2431280 T2431281 T2434584 T2446766 T2464347 T2467230 T2477524 T2489926 T2513657 T2514888 T2518078 T2519083 T2550611 T2565097 T2566133 T2581123 T2587792 T2597130 T2610002 T2611975 T2611988 T2617249 T2632088 T2638072 T2652386 T2652389 T2652395 T2652396 T2657105 T2662320 T2680774 T2680775 T2687130 T2687131 T2713157 T2719249 T2738068 T2762224 T2781710 T2783882 T2786106 T2801582 T2802364 T2816169 T2818676 T2821641 T2823720 T2823722 T2829990 T2829992 T2838973 T2847768 T2850599 T2850884 T2854426 T2854427 T2867188 T2868244 T2876373 T2900566 T2900613 T2912473 T2912528 T2919513 T2932986 T2940181 PC201/B 00884450015285 T2185313 T2202175 T2208175 T2223545 T2269053 T2299545 T2315080 T2329634 T2362892 T2387856 T2433239 T2434585 T2449544 T2466092 T2479275 T2489930 T2514797 T2526980 T2531782 T2570307 T2587793 T2617255 T2635760 T2644381 T2657107 T2687133 T2713158 T2719251 T2788686 T2801587 T2814910 T2823723 T2850602 T2867189 T2876376 T2906834 T2906835 T2939054 PC801 00884450054017 T2208911 T2223546 T2246244 T2262305 T2269054 T2299546 T2306252 T2306254 T2329635 T2340039 T2366375 T2385421 T2424129 T2434586 T2449545 T2466183 T2489931 T2512280 T2517981 T2517985 T2550612 T2560916 T2568528 T2570989 PC801/A 00884450727911 T2611953 T2614842 T2614843 T2652398 T2662321 T2680776 T2683104 T2728045 T2728051 T2776680 T2782961 T2801591 T2801592 T2814922 T2823728 T2843866 T2852104 T2867190 T2882457 T2906079 PC802 00884450052297 T2208176 T2232659 T2292460 T2310770 T2329636 T2351179 T2382097 T2403714 T2424130 T2449551 T2479277 T2535830 T2560917 T2568529 T2570994 PC802/A 00884450727928 T2611934 T2614844 T2626504 T2652399 T2728053 T2786076 T2816480 T2847783 T2871500 T2885490 T2906078 T2932988 T2933746
• Recalling Firm/ Manufacturer: Merit Medical Systems, Inc.; 1600 W Merit Pkwy; South Jordan UT 84095-2416
• For Additional Information Contact: 801-253-1600
• Manufacturer 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.
• FDA Determined Cause: No Marketing Application
• Action: On 06/11/2024, the firm sent an "URGENT MEDICAL DEVICE RECALL NOTICE" Letter to customers informing them that specific Merit Medical convenience kits contain plastic syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd. These syringes lack the appropriate/sufficient FDA market authorization. In addition, Merit Medical posted the Urgent Medical Device Recall letter and complete list of affected products/kits on their website at https://www.merit.com/products/documents/product-notices/. Customer are instructed to: 1. Immediately determine if any of the products identified in the attached Customer Response Form (CRF) are within their facility, quarantine them, and discontinue use and distribution. 2. Ensure that appropriate personnel within their organization are made aware of this field action. 3. If the product has been further distributed to other facilities, institutions, or manufacturers, ensure this notice is immediately shared with them. Additional distribution details may be required by health authorities. 4. Follow the attached instructions for placing the recall labels on the products containing Jiangsu Shenli syringes, which inform the users to not use the affected syringes. If additional recall labels are needed, contact Customer Service at (801) 208-4381. Product may be returned to inventory once properly over-labeled. 5.At the point of use, the Jiangsu Shenli syringes are to be discarded. Photographs of Jiangsu Shenli syringes are enclosed to assist in identification. 6.Post this URGENT MEDICAL DEVICE RECALL NOTICE and Jiangsu Shenli Syringe photographs on or near the affected products. 7.If replacement syringes are needed, contact Customer Service at (801) 208-4381 for recommended syringe suppliers. For questions contact Merit Sales Representative or Merit Customer Service at 801-208-4381, Hours: 6 am to 6 pm MST Mon.-Fri.
• Quantity in Commerce: 72115 kit
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.