FDA Enforcement Class II Terminated

McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, MFR # 16-NBCH21GS

Recall: Z-0207-2022 · Reported November 17, 2021

Enforcement

Recall Number
Z-0207-2022
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 Winged Blood Collection Needle with Tube Holder, MFR # 16-NBCH21GS

Reason

Potential for difficulty in safety mechanism activation.

Code Info

Lot Numbers / Expiration Dates: CKDI11-01 / Exp. Date 2024-10-01, CKDI12-01 / Exp. Date 2024-11-01, CKDJ01-01 / Exp. Date 2024-12-01, CKDJ03-01 / Exp. Date 2025-02-01, CKDJ05-01 / Exp. Date 2025-04-01, CKDJ05-03 / Exp. Date 2025-04-03, CKDJ06-01 / Exp. Date 2025-05-01.

Distribution

U.S. Nationwide distribution.

Quantity

N/A