FDA recall Z-0410-2018

Somatex Medical Technologies GmbH · Class II · device

Product

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.

Distribution

NY - Only one US distributor

Key facts

Status
Terminated
Initiation date
2017-05-22
Report date
2018-01-31
Termination date
2018-08-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Teltow, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0410-2018