Medical device manufacturer, Surgical Innovations Ltd, has issued a medical device safety alert concerning its instrument, 5/10/12mm Armoured Swing-top [Part number: YA512STSA; Lot number: 703340].
There is a labelling error on the above-mentioned product. The devices are sterile, however the label states non-sterile. In particular, the label on the device (primary packaging) is labelled incorrectly and states "non-sterile". The label on the carton (secondary packaging) is correct and states "sterile".
According to the manufacturer, this does not impact the quality of the product, the product is sterile and there is no risk to patient safety. A steri-dot is applied to each primary and secondary packaging to indicate the batch has been sterilised.
According to the local supplier, the affected products are not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 19 September 2017