Reported Feb 18, 2015 · Terminated

LMA (Laryngeal Mask Airway) Supreme (New Cuff) Size 5, Sterile, Single use, Product Usage: Achieve and maintain control…

Teleflex Medical

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: Teleflex Medical · 2917 Weck Dr · Research Triangle Park, NC · 27709-0186

Is this the product you have?

  • LMA (Laryngeal Mask Airway) Supreme (New Cuff) Size 5, Sterile, Single use
  • Product UsageAchieve and maintain control of airway during routine anaesthesia in fasted patient using either spontaneous or positive pressure ventilation, cardiopulmonary resuscitation, the failed intubation situation and the cannot-intubate-cannot-ventilate situation
Lot codes and dates
  • Catalog No(s)175050, Lot no. HMAUGK
Amount recalled
2640 units

This recall covers 18 products

The agency filed one notice per product. You are reading one of them; the other 17 are below.

5 more are in the archive.

Where it was sold

Why it was recalled

The labelling of units from the affected lot indicates that it contains a size 5 LMA Supreme (New Cuff), but may contain a size 4 LMA Supreme (New Cuff).

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 Sep 27, 2016 · Data as of Sep 19, 4:47 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.