Reported Jun 21, 2023 · Ongoing

Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992507, Version A, Sterile EO, Rx Only

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?

  • Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992507, Version A, Sterile EO, Rx Only
Lot codes and dates
    • Lot # I2548172
    • I2568218
    • I2553914
    • I2614174
    • I2638785
    • I2559299
  • UDI-DI00884450394915
Amount recalled
524 units

This recall covers 13 products

The agency filed one notice per product. You are reading one of them; the other 12 are below.

Where it was sold

Why it was recalled

There is a potential that valve assemblies will not open. preventing fluid from draining.

This product could cause temporary or reversible health problems — stop using it.

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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, 4:54 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.