Reported Jul 16, 2014 · Terminated

Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure…

RGI Medical Manufacturing, 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: RGI Medical Manufacturing, Inc. · 4637 NW 6th St · Gainesville, FL · 32609-0701

Is this the product you have?

  • Henora REF70-4026-09V1 300psi I.V
  • Catheter Extension Set Product UsageCatheter extension set for high pressure procedures
Lot codes and dates
  • Lot numbers 102131 and 110531.
Amount recalled
19,200 units.

Where it was sold

Why it was recalled

Problem with low adhesion of the tubing to luer connection which may lead to a separation of the extension set while in use.

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 Sep 29, 2016 · Data as of Sep 19, 6:04 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.