Reported Aug 21, 2024 · Ongoing
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K02…
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
- syringesK02 (Custom Syringe Kit)
- REFK02-00873A, Inject fluids into, or withdraw fluids from, the body
- Lot codes and dates
- Catalog NumberK02-00873A
- UDI-DI code00884450156261
- Lot NumbersH2597212
- H2620955 H2641148 Catalog NumberK02-01105A
- UDI-DI code00884450156124 H2486384
- H2542259 H2628908 Catalog NumberK02-01481A
- UDI-DI code
00884450164464H2387157H2418377H2472043H2486729H2507912H2517550H2526240H2552843H2595093H2628968H2655130H2678790H2699921H2712471H2747868H2822453H2831126H2846806H2868403H2884580H2897149H2916452
- Amount recalled
- 3,647 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.
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