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)
- REFOPT0242-00 S1279-01 S2953 S2960 S6002 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 OPT0242-0000884450400586T2167632 T2651487 T2327975 T2528428 T2845197 S1279-0100884450050804T2281682 T2409038 T2415675 T2449554 T2479912 T2599987 T2610007 T2681504 T2662328 T2713161 T2832455 T2890627 T2748983 T2780193 S295300884450050842T2538578 T2625990 T2548814 T2574370 T2643543 T2702839 T2702565S T2736331 T2801599 T2924139 T2839019 T2890680 T2847794 S296000884450389058T2542575 T2637160 T2872115 S60020088445005239T2208823 - Amount recalled
- 5700 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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