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 Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning Stryker Instruments, a Division of Stryker Corporation Pressure Tourniquet Cuffs - Color Cuff Single Port, Single Bladder 34" (Purple), Quick Connect [Part number: 5921034135; Lot Number: 60394560; Order Number: 2354241] [HKMD No.: 200405].
According to MHRA, the manufacturer was informed by the sterilizer that reprocessed pressure tourniquet cuffs had been shipped under purchase orders for non-reprocessed products. The reprocessed pressure tourniquet cuffs are manufactured to specification and are labelled as reprocessed items, however, cannot be sold in the UK.
For further information, please visit https://mhra-gov.filecamp.com/s/d/f4QUPrZmOq7YcmUu
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 1 Feb 2024