FDA Recall
Terminated
McKesson PREVENT HT Safety Blood Collection Needles, 21G 1 1/4 inch, MFR # 16-NBC21GS
Recall: Z-0204-2022
·
Initiated August 24, 2021
Recall
- Recall Number
- Z-0204-2022
- Event Number
- 88757
- Firm
- Zhejiang Kindly Medical Devices Co., Ltd. # 758 Binghai Five Rd. Longwan Dist Wenzhou China
- FEI Number
- 3003560965
- Product Code
- FMI
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- August 24, 2021
- Terminated
- July 21, 2023
Description
McKesson PREVENT HT Safety Blood Collection Needles, 21G 1 1/4 inch, MFR # 16-NBC21GS
Reason
Potential for difficulty in safety mechanism activation.
Action
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.
Distribution
U.S. Nationwide distribution.