It has come to our attention that there is a quality issue concerning intra-uterine contraceptive device manufactured by Mona Lisa N.V (Model number: CuT 380A, Lot number: 2012-K-30).
On 7 March 2013 morning, during random spot checking before product distribution to Maternal and Child Health Centres (MCHCs), the Family Health Service (FHS) of the Department of Health (DH) found that some products of the lot (2012-K-30) have black hair or thread-like substance within the sterile packaging. The affected products have not yet been distributed to the MCHCs. According to the local supplier, CNW Far East Ltd., the affected lot has only been distributed to FHS of DH and it has not received similar complaints from other users. So far the local supplier has not received any information from the manufacturer about recall of the affected product. DH instructed the local supplier to recall the affected lot from the user. Investigation is ongoing.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 8 March 2013