Reported Aug 1, 2018 · Terminated

Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of…

Terumo Cardiovascular Systems Corp.

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: Terumo Cardiovascular Systems Corp · 28 Howe St · Ashland, MA · 01721-1305

Is this the product you have?

  • Tubing Pack Convenience Kit
  • Product Code 65217 Product UsageIntended for use only in the extracorporeal circuit of the cardiopulmonary bypass procedures for which the user designed it
Lot codes and dates
  • Lot NumberVE17
Amount recalled
30 cases/2 units (Total 60 units)

Where it was sold

Why it was recalled

Kit was labeled with the incorrect Expiration Date of April 30, 2019.

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

Notice updated Oct 26, 2018 · Data as of Sep 19, 6:47 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.