UK MHRA has issued a Medical Device Alert relating to Molnlycke Health Care ProcedurePaks® with devices containing latex, which have been labelled as latex-free.
Action is required by all healthcare workers who use these devices, and personnel involved in the purchase, supply and distribution of these devices. Required actions include identification of all affected unused product for return to the manufacturer. The field safety notice (FSN) was issued on October 25th, but the manufacturer has not had sufficient confirmation from users that they have received and acted on this information, which has resulted in this MDA.
The FSN can be found here.
This post has been extracted rom the full MHRA MDA, which can be found here. The action is required to be completed by January 5th 2012.Source: MHRApublished: December 13, 2011 in: Alerts/Adverse Events, Healthcare, Recalls, Regulatory