Merit Medical Systems, Inc.: Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: PC (Pericardiocentesis Tray - Fluid drainage tray), REF:

Hazard

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.

Details from the source

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. 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. Quantity: 72115 kit Lot/code info: 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

UPC codes

00884450015278, 00884450015285, 00884450054017, 00884450727911, 00884450052297, 00884450727928

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.