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.
Medical device manufacturer, Applied Medical Resources Corporation, has issued a medical device safety alert concerning its Kii Trocars - 12x100 Kii Blunt Tip Access System and 12x100 Kii Fios First Entry, Advanced Fixation, Handled [Model Number: C0R85 and CFF74] [HKMD No.: 180295].
According to the manufacturer, product primary packaging labels on these specific lots list the incorrect Global Trade Item Number (GTIN) in the barcode. Models C0R85 and CFF74 for the affected lots both contain the GTIN of model C0Q19 (8x100 Kii Optical Access System, Z-thread).
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 04 Jul 2024