Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

McKesson PREVENT HT Safety Blood Collection Needles, 22G 1 1/4 inch, MFR # 16-NBC22GS

FDA Recall Z-0205-2022 · Posted None

Recalling FirmZhejiang Kindly Medical Devices Co., Ltd.
Recall StatusTerminated
Product CodeFMI
Date Initiated2021-08-24
Date Terminated2023-07-21

Reason for Recall

Potential for difficulty in safety mechanism activation.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

U.S. Nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑