Z-0410-2018 Class II Terminated

Recalled by Somatex Medical Technologies GmbH — Teltow, N/A

Recall Details

Product Type
Devices
Report Date
January 31, 2018
Initiation Date
May 22, 2017
Termination Date
August 30, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

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.

Distribution Pattern

NY - Only one US distributor

Code Information

Lot numbers: 47883, 47910 & 47911