FDA Enforcement
Class II
Terminated
McKesson PREVENT HT Safety Blood Collection Needles, 21G 1 1/4 inch, MFR # 16-NBC21GS
Recall: Z-0204-2022
·
Reported November 17, 2021
Enforcement
- Recall Number
- Z-0204-2022
- Event ID
- 88757
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Zhejiang Kindly Medical Devices Co., Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 17, 2021
- Initiation Date
- August 24, 2021
- Classification Date
- November 5, 2021
- Termination Date
- July 21, 2023
- Address
- # 758 Binghai Five Rd., Longwan Dist, Wenzhou, N/A, N/A, China
Description
McKesson PREVENT HT Safety Blood Collection Needles, 21G 1 1/4 inch, MFR # 16-NBC21GS
Reason
Potential for difficulty in safety mechanism activation.
Code Info
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.
Distribution
U.S. Nationwide distribution.
Quantity
N/A