FDA Medical Device Recalls (openFDA)
Zhejiang Kindly Medical Devices Co., Ltd.: HENRY SCHEIN Safety Blood Collection Needle 22Gx 1 1/4 Inch, REF 570-2068, 100pcs/box 1000pcs/ctn 350*210*350mm
- Recall number
- Z-0209-2022
- Recalling firm
- Zhejiang Kindly Medical Devices Co., Ltd.
- Product
- HENRY SCHEIN Safety Blood Collection Needle 22Gx 1 1/4 Inch, REF 570-2068, 100pcs/box 1000pcs/ctn 350*210*350mm
- Status
- Terminated
- Initiated
- 2021-08-24
- Posted
- not on file
- Terminated
- 2023-07-21
- Reason
- Potential for difficulty in safety mechanism activation.
- Root cause
- Nonconforming Material/Component
- 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.
- Quantity
- not on file
- Distribution
- U.S. Nationwide distribution.
- Lot, serial or model codes
- Lot Numbers / Expiration Date: 20201030 / Exp. Date 2025.10.29, 20201210 / Exp. Date 2025.12.09.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FMI
- Firm FEI
- 3003560965
- Firm city
- Wenzhou
- Firm state
- not on file
- Firm country
- China
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28