Medical device manufacturer, Medline Industries, Inc., has issued a medical device safety alert concerning its NAMIC MANIFOLD and STOPCOCKS [Multiple items and lots].
The manufacturer has confirmed a breach in the sterile barrier via pressurisation testing of some of their single sterile stopcock and manifold packaging. The investigation, to date, concluded that microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions. Use of a potentially non-sterile stopcock could lead to a risk of infection which could be local, or systemic in nature.
Users are advised to check their stock for the affected item and lot numbers, then to quarantine all affected products. If there is transferred possession of these products to another individual, to another department or another location in the organisation, users should notify them of this recall communication. Customers should return any affected product for collection and return to the manufacturer.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary action.
Posted on 11 Aug 2021