FDA
McKesson PREVENT HT Safety Blood Collection Needles, 21G 1 1/4 inch, MFR # 16-NBC21GS
Potential for difficulty in safety mechanism activation.
On 8/24/2021, Zhejiang Kindly Medical Devices Co., Ltd. issued Urgent Medical Device Safety Alert notices to two customers. On 9/17/2021, issued a second notice to customers dated 8/24/2021.
Action to be Taken by User:
1 - Advise the user to lower the angle between safety protective cap and needle tube by slight pressing in the direction of activation, then using a thumb or hard surface to activate the safety protective cap and lock the needle tube in the IFU, then together with corresponding illustration.
2 - Request the user to strictly follow the guidance of the IFU.