Reported Aug 21, 2024 · Ongoing
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K11…
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
- syringesK11 (Custom Pressure Monitoring Kit)
- REFK11-00382C To support fluid administration into the body and physiological pressure monitoring. To support various vascular or cardiac diagnostic and interventional procedures
- Lot codes and dates
- Catalog Number/UDI-DI code/Lot Numbers
K11-00382C00884450158425H2379628H2531736H2536619H2813488H2881603H2916468
- Catalog Number/UDI-DI code/Lot Numbers
- Amount recalled
- 69 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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