Reported Apr 19, 2023 · Ongoing

Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A

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?

  • Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
Lot codes and dates
  • Catalog NumberCE-1400/A
  • UDI-DI Code00884450170069
  • Lot NumberH2586496
Amount recalled
17 devices

Where it was sold

Why it was recalled

Product that was built for design verification testing was inadvertently distributed to customers.

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, 5:38 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.