Reported Nov 27, 2019 · Terminated

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system,…

Cook 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: Cook Inc. · 750 N Daniels Way · Bloomington, IN · 47404-9120

Is this the product you have?

  • Torcon
  • NB Advantage Catheters - Product UsageIntended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques
Lot codes and dates
  • REF (RPN)HNB5.0-38-80-P-NS-EKISAI-111984
  • REF (GPN)G10796
  • Lot NumberNS9904740
  • UDI(01)00827002107960(17)220801(10)NS9904740
Amount recalled
10

This recall covers 74 products

The agency filed one notice per product. You are reading one of them; the other 73 are below.

61 more are in the archive.

Where it was sold

Why it was recalled

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

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 Jun 30, 2020 · Data as of Sep 19, 4:46 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.