FDA Device

McKesson PREVENT HT Safety Blood Collection Needles, 21G 1 1/4 inch, MFR # 16-NBC21GS

Hazard

Potential for difficulty in safety mechanism activation.

What You Should Do

Remedy

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.

Products

McKesson PREVENT HT Safety Blood Collection Needles, 21G 1 1/4 inch, MFR # 16-NBC21GS
Brand
Zhejiang Kindly Medical Devices Co., Ltd. # 758 Binghai Five Rd. Longwan Dist Wenzhou China
UPC
lot numbers / Expiration Date: CDI11-01 / Exp. Date 2024-10-01, CDKI11-02 / Exp. Date 2024-10-02, CKI12-01 / Exp. Date 2024-11-01, CKDJ01-01 / Exp. Date 2024-12-01, CKDJ05-01 / Exp. Date 2025-04-01, CKDJ06-01 / Ex. Date 2025-05-01.