Reported Oct 15, 2014 · Terminated

Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number…

Sterilmed, 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: STERILMED, INC. · 11400 73rd Ave N · Maple Grove, MN · 55369-5561

Is this the product you have?

  • Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters
  • Catalog Nos
    • M-5723-115
    • Model Number BIO10438577
Lot codes and dates
  • Lot Numbers
    • 1717945
    • 1721574
    • 1721575
  • and 1723123 Catalog Nos
    • M-5723-115
    • Model Number BIO10438577
Amount recalled
22

Where it was sold

Why it was recalled

Sterilmed, a division of Johnson & Johnson Medical NV/SA (Sterilmed), has become aware of an issue affecting certain lots of Reprocessed SOUNDSTAR® eco Diagnostic Ultrasound Catheters for which Sterilmed is the reprocessor and Biosense Webster is the distributor. Sterilmed determined that the units of these lots were incorrectly processed and as a result when the affected catheter is conne

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 Aug 11, 2015 · Data as of Sep 19, 4:48 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.