Exact FDA event identifier

Event 78349

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: May 22, 2017
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Somatex Medical Technologies GmbH

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-0410-2018

Recall number: Z-0410-2018
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Somatex Medical Technologies GmbH
Quantity: N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

packaging material which can compromise the devices sterility, making it non-sterile

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot numbers: 47883, 47910 & 47911

Distribution pattern

NY - Only one US distributor