Important Safety Alerts

It has come to the attention of the Medical Device Control Office that several Maternal and Child Health Centres of the Department of Health have reported incidents relating to disposable vaginal speculums manufactured by Taizhou Kangjian Medical Equipment Co., Ltd. The incidents involved breakage of the handles and/or blades of the speculums, dislodgement of screwing rods and presence of black debris inside the packages.

The affected vaginal speculums are identified as follows:

• Cusco style, sterile, 105 mm (length) x 22 mm (width), model number TA3201, lot number 20150320
• Cusco style, sterile, 130 mm (length) x 28 mm (width), model number TA3203, lot number 20150320

The issues have been reported to the local supplier, Tin Ho Enterprises Co. Ltd. and investigation is underway.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 18 May 2016