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, Terumo Blood and Cell Technologies APC-30 PROCEDURE PACK [lot 08F9928 of Catalog/REF 51404] [HKMD No.: 160089].
The manufacturer is informing users that the affected product contains an IV Start Pack that has an expiration date of 11/2023 based on the expiration date of the alcohol swabs and PVP-iodine ampules within the pack. However, the outer kit packaging has an expiration date of 07/2024. According to the manufacturer, the use of isopropyl alcohol swabs and PVP-iodine ampules after the IV Start Pack’s 11/2023 expiration date may have some reduced efficacy as an antimicrobial skin preparation.
The manufacturer advises users that when unpacking the set, the IV Start Pack component has an expiration date of 11/2023. If this expiration date has passed, do not use the IV Start Pack component of the kit.
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 09 Mar 2023