Reported Feb 27, 2013 · Terminated

Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO) for the treatment of respiratory…

Maquet Cardiovascular US Sales, LLC

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: Maquet Cardiovascular Us Sales, Llc · 45 Barbour Pond Drive · Wayne, NJ · 07470

Is this the product you have?

  • Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO) for the treatment of respiratory insufficiency in infants.
Lot codes and dates
  • US Distribution Part number 701017471 Lot numbers 92046825 92065723 92076940 OUS Distribution Part Number Lot Numbers

    66 of 66 codes

    • 701002797
    • 92050616
    • 701002797
    • 92052823
    • 701002797
    • 92052913
    • 701002797
    • 92058153
    • 701002797
    • 92063518
    • 701002797
    • 92068260
    • 701002797
    • 92069267
    • 701002797
    • 92072177
    • 701002797
    • 92075413
    • 701002797
    • 92077862
    • 701005092
    • 92081862
    • 701005092
    • 92049129
    • 701005092
    • 92070554
    • 701005093
    • 92049130
    • 701005093
    • 92056899
    • 701005093
    • 92065588
    • 701005093
    • 92069429
    • 701005093
    • 92070553
    • 701005093
    • 92071852
    • 701005093
    • 92073598
    • 701005093
    • 92076875
    • 701017471
    • 92076940
    • 701046644
    • 92063587
    • 701050978
    • 92047882
    • 701050978
    • 92053930
    • 701050978
    • 92054156
    • 701050978
    • 92056171
    • 701050978
    • 92056804
    • 701050978
    • 92065094
    • 701050978
    • 92067382
Amount recalled
41 units - US Distirbution; 216 units - OUS Distribution

Where it was sold

Why it was recalled

ELS 15 Fr Cannula could potentially contain an occluded arterial lumen.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 8, 2014 · Data as of Sep 19, 5:29 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.