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.
The United States Food and Drug Administration (FDA) has posted a medical device safety alert concerning Medtronic Medline Sprinter OTW [Model/Catalog Number SPR2512W; GTIN/UPN 00643169850491, Lot Number: 222066656 Expiration Date: 04/13/2023] [HKMD No.: 090301].
According to the FDA, luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=90552
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 10 Aug 2022