TUMARK Q recalled over sterility concerns
- Recall date
- May 22, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Somatex Medical Technologies GmbH recalls TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE
- Recall number
- Z-0410-2018
- FDA classification
- Class II
- Brand / firm
- Somatex Medical Technologies GmbH
- Sold / distributed
- NY - Only one US distributor
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE
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