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