FDA-Device2024-08-21Class II
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Safety Paracentesis Procedure Tray (Paracentesis Tray kit), REF: SPPT-100/D SPPT-5F-10/D SPPT-5F-10L/B SPPT-5F-10S SPPT-5F-12PL SPPT-5F-17PL SPPT-5F-7/D SPPT-5F-7L/B SPPT-5F-7S SPPT-6F-10L SPPT-6F-10S SPPT-6F-10S SPPT-6F-12PL SPPT-6F-17PL SPPT-8F-10L SPPT-8F-12PL TAPS-100 TAPS-5F-10LT TAPS-5F-10T TAPS-5F-12PLT TAPS-5F-17PLT TAPS-5F-7LT TAPS-5F-7T TAPS-6F-10
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
317115 kits
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: Safety Paracentesis Procedure Tray (Paracentesis Tray kit), REF: SPPT-100/D SPPT-5F-10/D SPPT-5F-10L/B SPPT-5F-10S SPPT-5F-12PL SPPT-5F-17PL SPPT-5F-7/D SPPT-5F-7L/B SPPT-5F-7S SPPT-6F-10L SPPT-6F-10S SPPT-6F-10S SPPT-6F-12PL SPPT-6F-17PL SPPT-8F-10L SPPT-8F-12PL TAPS-100 TAPS-5F-10LT TAPS-5F-10T TAPS-5F-12PLT TAPS-5F-17PLT TAPS-5F-7LT TAPS-5F-7T TAPS-6F-10LT The Safety Paracentesis Procedure Tray is intended for drainage of fluid and specimen collection for diagnostic purposes or to remove excess fluid collections.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2576-2024More Merit Medical Systems, Inc. recalls
- FDA-Device2026-04-01Merit Medical CentrosFLO Hemodialysis Catheters recalled for sheath splitting defect
- FDA-Device2026-04-01Merit Medical ProGuide Chronic Dialysis Catheters recalled for sheath introducer design defect
- FDA-Device2026-04-01Merit Medical Systems 16F splittable sheath introducer recalled for design defect causing failure to split
- FDA-Device2026-04-01Merit Medical BioFlo DuraMax Catheter recalled for design defect in sheath introducer
- FDA-Device2026-04-01Merit Medical DuraMax hemodialysis catheter recalled for sheath introducer design defect
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