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Terminated

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

FDA Recall Z-0410-2018 · Posted None

Recalling FirmSomatex Medical Technologies GmbH
Recall StatusTerminated
Product CodeNEU
Date Initiated2017-05-22
Date Terminated2018-08-30

Reason for Recall

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

Firm Action

On May 22, 2017, Somatex Medical Technologies distributed notices to their customers advising them of the reason for recall. Customers are advised to inspect stock, quarantine and not use affected product. Products will be exchanged free of charge and a replacement delivery will be arranged promptly. All customers are expected to complete and return the response form via fax.

Root Cause

Device Design

Distribution Pattern

NY - Only one US distributor

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K073095TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560Somatex Medical Technologies GmbH · 2008-03-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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