Field Safety Notices about Infusion set

Croatian data is current through September 2015. All of the data comes from the Agency for Medical Products and Medical Devices of Croatia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Croatia.

The Agency for Medicinal Products and Medical Devices (HALMED) has received the information from the medical device wholesaler Ma-Co Plast d.o.o, about the preventive recall of the LOT 2013-01 of the Infusion Set due to its non-conformity with the Regulation (EC) 1907/2006.
The decision about the preventive recall has been taken in collaboration with HALMED, after the test results of the aforementioned medical device lot revealed that the content of bis(2-ethylhexyl)ftalate was above the maximum allowed level set out in the Regulation (EC) 1907/2006.
The end users are informed in a letter to quit preventively using transfusion sets from the same manufacturer Shandong Qiaopai Group Co,. Ltd and separate them from other products before the test results have been obtained.
Here you may read the letter to the end users.
No adverse incident related to this medical device has been reported in the Republic of Croatia by now.