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, BD has issued a medical device safety alert concerning its BD Ultra-Fine Insulin Syringe 0.5mL; BD Insulin Syringes with the BD Micro-Fine IV Needle U-100 Insulin Doses up to 100 units Single Unit Scale; BD Insulin Syringes with the BD Micro-Fine IV Needle U-100 Insulin Doses up to 100 units Two Unit Scale; BD Ultra-Fine Insulin Syringe 0.5mL; BD Ultra-Fine Insulin Syringe 1mL; BD Insulin Syringes with the BD Micro-Fine IV Needle U-100 Insulin Doses up to 50 units Single Unit Scale; BD Ultra-Fine Insulin Syringe 1mL; BD Ultra-Fine II Insulin Syringe 0.5mL [Catalog (Ref) No.: 326679, 329420, 329424, 326713, 326678, 329461, 326719, 326725; Multiple Lot No.] [HKMD No.: 100035].
The manufacturer is informing users that the affected product was manufactured using unvalidated materials that can result in unsealed packaging for the individual syringes. If the Blister Pack of the syringe has a non-intact seal then there is a potential that the syringe is no longer sterile. According to the manufacturer, use of a non-sterile syringe poses the risk of a local skin infection which may require medical treatment such as the use of antibiotics.
The manufacturer advises affected user to identify, discontinue use, and return all affected product.
According to the local supplier, the affected products are distributed in Hong Kong.
For further information, please visit:
https://bdx.force.com/CC360/s/impactedproducts?language=en_US&id=7018a000001x41KAAQ
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 8 Feb 2023