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Terminated

HENRY SCHEIN Safety Blood Collection Needle 22Gx 1 1/4 Inch, REF 570-2068, 100pcs/box 1000pcs/ctn 350*210*350mm

FDA Recall Z-0209-2022 · 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.

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