Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning Ethicon, Inc Coated VICRYL Plus Antibacterial (polyglactin 910) Suture [Product Code: VCP1226H, Lot: SJBCGZS0] [HKMD No.: 080200].
According to the MHRA, the manufacturer has initiated a voluntary medical device recall (removal) of one lot of Coated VICRYL Plus Antibacterial (polyglactin 910) Suture, Product code VCP1226H, Lot SJBCGZS0. Through an internal investigation following a customer complaint, the manufacturer determined that five eaches of product were distributed with the foil packaging open on the non-peelable side which would result in a sterility breach.
For further information, please visit https://mhra-gov.filecamp.com/s/d/vWHooEZTKvTPbcqW
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 13 Sep 2023