Medical device manufacturer, Karl Storz, has issued a medical device safety alert concerning its Insufflation Filter. [Item Code: 031122-25/031122-01; Lot: 18L0473FAX, 18L0474FAX, 18L0475FAX, 18L1286FAX, 18L1287FAX, 19C0145FAX, 19D0638FAX, 19E0681FAX, 19E0682FAX, 19J0567FAX, 19K0524FAX, 19K1052FAX, 20A0688FAX, 20A0689FAX, 20B0623FAX, 20C0679FAX, 20E1017FAX, 20E1018FAX, 20F1129FAX, 20F1131FAX, 20F0942FAX, 20F0943FAX]
The manufacturer was informed about potential deviations of validated parameters for ethylene oxide sterilisation at sterilisation provider, Steril Milano. The deviations affect certain production LOTs of Insufflation Filter 031122-25 between March 2018 and February 2021. According to the manufacturer, it has conducted sterile testing with products available (LOT 20F0942FAX & LOT 20F0943FAX) and identified that one of two tested LOTs, LOT 20F0943FAX, developed bacterial growth. The manufacturer will recall all the affected LOTs.
According to the local supplier, the products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary action.
Posted on 28 May 2021