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
- syringesPrelude SNAP (Introducer Catheter kit)
- REFFor the introduction of various types of pacing leads and catheters to the heart and coronary venous system
- Lot codes and dates
17 of 17 products
Products covered by this recall Model / number Barcodes Product as published PLS-1006/A00884450467954I2868407 I2873488 I2884101 I2889284 I2889285 I2889286 I2889287 I2889289 I2889288 I2903937 I2903938 I2903939 I2914399 I2925168 I2925169 PLS-1007/A00884450467985I2790541 I2862963 I2868410 I2868412 I2873489 I2882475 PLS-1008/A00884450467992I2868415 I2884088 I2889299 I2889300 I2661407S1 I2661408S1 I2925190 PLS-1009.5/A00884450468036I2862967 I2873494 I2889301 I2925173 PLS-1009/A00884450468012I2790564 I2873496 I2884103 I2889303 I2889306 PLS-1010.5/A00884450468050I2862970 PLS-1010/A00884450468043I2873497 I2873498 I2873499 I2873500 I2889327 PLS-1011/A00884450468067I2889329 PLS-2506/A00884450468098I2873501 I2889331 I2914419 PLS-2508/A00884450468111I2889334 PLS-2509/A00884450468128I2687649S1 I2868417 I2914426 PLS-2510/A00884450468135I2873503 I2889336 PLS-2511/A00884450468159I2889337 PLSX-1006/A00884450489550I2868420 I2873516 I2889355 I2914466 PLSX-1007/A00884450489567I2868421 I2873517 I2883775 I2903957 I2932677 PLSX-1008/A00884450489574I2889357 PLSX-1009/A00884450489598I2914468 - Amount recalled
- 55305
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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