Somatex Medical Technologies GmbH: Medical Device Recall in 2018 - (Recall #: Z-0410-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 22, 2017

Date Posted: January 31, 2018

Recall Number: Z-0410-2018

Event ID: 78349

Reason for Recall:

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

Status: Terminated

Product Quantity: N/A

Code Information:

Lot numbers: 47883, 47910 & 47911

Distribution Pattern:

NY - Only one US distributor

Voluntary or Mandated:

Voluntary: Firm initiated