FDA-Device2024-08-21Class II
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP (Introducer Catheter kit), REF: For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
Merit Medical Systems, Inc.
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.
Sold states
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.
Affected count
55305
Manufactured in
1600 W Merit Pkwy, South Jordan, UT, United States
Products
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP (Introducer Catheter kit), REF: For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2574-2024Don't want to check this manually?
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