Reported Aug 21, 2024 · Ongoing

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:…

Merit Medical Systems, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Merit Medical Systems, Inc. · 1600 W Merit Pkwy · South Jordan, UT · 84095-2416

Is this the product you have?

  • Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd
  • syringesCustom Procedure Kit (Angiography/angioplasty kit)
  • REFK12T-10773 K12T-09284D K12T-10621 K12T-10800 K12T-12491 To support various vascular or cardiac diagnostic and interventional procedures
Lot codes and dates

5 of 5 products

Products covered by this recall
Model / numberBarcodesProduct as published
K12T-1077300884450426388T2800379 T2824129 T2849013 T2857243
K12T-09284D00884450602102T2209872 T2220946 T2359067 T2364198 T2508160 T2674429 T2794927 T2800155
K12T-1062100884450409435T2308653 T2344516 T2411888 T2428905 T2429939 T2448507 T2452908 T2473123 T2498967 T2531706 T2597113 T2611405 T2629759 T2653268 T2685014 T2691082 T2715028 T2744136 T2776727 T2846077 T2873111
K12T-1080000884450421093T2280633 T2407018 T2503204 T2643484 T2680463 T2705035 T2885158
K12T-1249100884450820605T2905902
Amount recalled
11837 kits

This recall covers 23 products

The agency filed one notice per product. You are reading one of them; the other 22 are below.

10 more are in the archive.

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Merit Medical Systems, Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:54 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.