Device Recall Tumark Q 의 리콜

Recall

78349

Class 2

Z-0410-2018

2017-05-22

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159289

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

On May 22, 2017, Somatex Medical Technologies distributed notices to their customers advising them of the reason for recall. Customers are advised to inspect stock, quarantine and not use affected product. Products will be exchanged free of charge and a replacement delivery will be arranged promptly. All customers are expected to complete and return the response form via fax.