Multiload Radiopaque Cu375 intrauterine contraceptive devices 의 안전성 경고

Safety alert

2013-03-27

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/press_20130327.html

Recall of multiload radiopaque cu375 intrauterine contraceptive devices (with photos) the department of health (dh) today (march 26) instructed a local medical device supplier, merck sharp & dohme (asia) limited to recall one lot of multiload radiopaque cu375 intrauterine contraceptive devices (iucds), manufactured by an irish company, multilan ag, following discovery of impurities inside the packing of a number of devices. the discovery was made by dh's family health service (fhs) when they conducted routine inspection of stock prior to distributing the devices for use by their maternal and child health centres (mchcs). among some 300 iucds inspected belonging to lot number sm-3337-13, 4 devices were found to contain tiny hair-like or dust-like impurities inside their sterile pouches. so far, mchcs have not used iucds from the affected lot. the fhs reported the issue to the supplier as well as the medical device control office, which began investigation immediately. according to the supplier, about 950 devices from the affected lot were distributed to public and private hospitals and some private clinics. the dh has not received any relevant report of adverse incidents in hong kong. as a precautionary measure, the supplier is instructed to conduct a batch recall of the product with lot number sm-3337-13 from the market. the supplier has set up a hotline (3971 2913) for enquiries. healthcare professionals should stop using the affected products immediately. dh has brought the matter to relevant stakeholders' attention and will follow up on the investigation. ends.