Merit Medical Systems, Inc.: Medical Device Recall in 2024 - (Recall #: Z-2560-2024)

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K02 (Custom Syringe Kit), REF: K02-00873A, Inject fluids into, or withdraw fluids from, the body.

Class II

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.

Catalog Number: K02-00873A UDI-DI code: 00884450156261 Lot Numbers: H2597212 H2620955 H2641148 Catalog Number: K02-01105A UDI-DI code: 00884450156124 H2486384 H2542259 H2628908 Catalog Number: K02-01481A UDI-DI code: 00884450164464 H2387157 H2418377 H2472043 H2486729 H2507912 H2517550 H2526240 H2552843 H2595093 H2628968 H2655130 H2678790 H2699921 H2712471 H2747868 H2822453 H2831126 H2846806 H2868403 H2884580 H2897149 H2916452

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.

Voluntary: Firm initiated