Stomach tube ch 18 에 대한 현장 안전성 서한

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.

Medicina trgovina d.o.o., the holder of the registry enrollment of the medical device has in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) decided to urgently recall one lot of the stomach tube CH 18 medical device of the manufacturer Changshu Taining Medical Equipment Co. Ltd, China due to a suspected product quality defect. The LOT 20100120 is being recalled by this decision.
On 26 July 2012, HALMED received a report from a health care facility about an unopened, sterile packaging of the aforementioned product in which, through a protective folio, a strange body that may possibly cause a contamination of the product, was observed. Therefore, HALMED informed the holder of the enrollment registry, who from precautions decidet to recall the aformentioned lot.
The stomach tube CH 18 is used for aspiration of the gastric content and it is intended for use in health care facilities.
Medicina trgovina do.o., the holder of the registry enrollment of the medical device has informed health care facilities in Croatia about the recall of the aforementioned lot found on the Croatian market.
In the Republic of Croatia has not been reported any adverse event associated with the described problem with the stomach tube CH 18 medical device.
The aforementioned lot of the medical device will be recalled untill the end of validity testing of other packagings of the same lot.