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-H (Introducer Catheter kit)
  • REFPLSH-1006/A PLSH-1007/A PLSH-1008/A PLSH-1009.5/A PLSH-2506/A PLSH-2507/A For the introduction of various types of pacing leads and catheters to the heart and coronary venous system
Lot codes and dates

6 of 6 products

Products covered by this recall
Model / numberBarcodesProduct as published
PLSH-1006/A00884450495049I2868424
PLSH-1007/A00884450495056I2889342 I2903951
PLSH-1008/A00884450495087I2873505
PLSH-1009.5/A00884450495568I2873507
PLSH-2506/A00884450495490I2872319 I2914441
PLSH-2507/A00884450495506I2868427 I2889346
Amount recalled
745 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:00 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.