Medical device manufacturer, Baxter Healthcare, has issued a medical device safety alert concerning the following:
- Y-Type irrigation set [Product Code: E5MC4007N; Lot Number: 16F13T674, 16H12T343, 17C02T778, 17D01T801, 18G07T033, 18H15T342]
- Spike with Clearlink (valve) [Product Code: EMC1402; Lot Number: 18F03T694N, 19C15T730N]
- Fast flow Y-type Irrigation set [Product Code: EMC4015N; Lot Number: 16F14T705, 16G01T063, 16I18T679, 17I05T665N, 18A21T145N, 18B03T558N]
- Secondary Medication Set [Product Code: EMC5930; Lot Number: 19C12T664]
- Y-Type Blood/Solution Infusion Set with Clearlink Injection Site, Luer Lock Adaptor [Product Code: FNC1173N; Lot Number: 18K28V537]
- Solution Administration Set with Clearlink [Product Code: MMC9668L; Lot Number: 20E04T335]
- Solution Administration Set [Product Code: MMC96900L, MMC96901L; Lot Number: 18J02T141, 20A21T052]
- Light Sensitive Drugs Set [Product Code: VMC9607C; Lot Number: 16F23T684, 16K23T354, 16K24T434, 17D04T805, 18B18T489, 18I03T686]
- Vented Paclitaxel Set [Product Code: VMC9627; Lot Number: 16L11T672, 17B01T300, 17C28T720, 17J21T115, 17L17T771, 18B21T492, 18I19T762]
According to the manufacturer, the affected products may not have been properly sterilised, or adequate documentation of sterilisation was not provided by one of the third party sterilisation providers. The manufacturer stated that after a thorough review the risk is considered to be low, however, to keep patients as safe as possible they are recalling the potentially impacted lots listed above.
The manufacturer advises users to locate, remove and return all affected products. The product code and lot number can be found on the individual product and shipping carton.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 27 May 2021