Recall Z-0410-2018— Somatex Medical Technologies GmbH

Name: FDA recall Z-0410-2018
Creator: U.S. Food and Drug Administration
Published: 2017-05-22

Class II · Terminated

Class II FDA medical device recall by Somatex Medical Technologies GmbH, initiated 2017-05-22, terminated 2018-08-30. It names one FDA 510(k) clearance: K073095. Product: TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE. Reason: There is a potential risk of puncture to the packaging material which can compromise the devices sterility, making it non-sterile..

Recalling firm: Somatex Medical Technologies GmbH
Classification: Class II
Status: Terminated
Initiated: 2017-05-22
Terminated: 2018-08-30
Firm location: Teltow, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K073095 — TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560Somatex Medical Technologies GmbH·cleared 2008-03-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.