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Recall Observatory FDA recall evidence

Device product

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

Z-0204-2022

August 24, 2021

Class II

Product summary

Firm
Zhejiang Kindly Medical Devices Co., Ltd.
Event
Event 88757
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-0204-2022

Official wording

Reason: Potential for difficulty in safety mechanism activation.

Code information: 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 pattern: U.S. Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for difficulty in safety mechanism activation.