Reported Jan 31, 2018 · Terminated

TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE

Somatex Medical Technologies GmbH

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: Somatex Medical Technologies GmbH · Rheinstr. 7 d · Teltow, N/A · N/A

Is this the product you have?

    • TUMARK Q
    • Length 12 cm
    • Diameter 18G
    • GTIN 04250195603081
    • REF 271500
    • STERILE
Lot codes and dates
  • Lot numbers
    • 47883
    • 47910 & 47911
Amount recalled
N/A

Where it was sold

Why it was recalled

There is a potential risk of puncture to the packaging material which can compromise the devices sterility, making it non-sterile.

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 30, 2018 · Data as of Sep 19, 6:48 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.