Z-0208-2022Class II

HENRY SCHEIN Safety Blood Collection Needle 21Gx 1 1/4 Inch, REF 570-2067, 100pcs/box 1000pcs/ctn...

Name: Z-0208-2022 HENRY SCHEIN Safety Blood Collection Needle 21Gx 1 1/4 Inch, REF 570-2067, 100pcs/box 1000pcs/ctn...
Creator: Zhejiang Kindly Medical Devices Co., Ltd.
Published: 2021-08-24
License: https://open.fda.gov/license/

Zhejiang Kindly Medical Devices Co., Ltd. / initiated 2021-08-24 / Terminated / root cause: manufacturing process

FDA source

Zhejiang Kindly Medical Devices Co., Ltd. began a recall of HENRY SCHEIN Safety Blood Collection Needle 21Gx 1 1/4 Inch, REF 570-2067, 100pcs/box 1000pcs/ctn 350*210*350mm on 2021-08-24. FDA classified it as Class II and gives the reason as "Potential for difficulty in safety mechanism activation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0208-2022
Classification: Class II
Status: Terminated
Initiated: 2021-08-24
Posted: 2021-11-05
Terminated: 2023-07-21
Recalling firm: Zhejiang Kindly Medical Devices Co., Ltd.
Product: HENRY SCHEIN Safety Blood Collection Needle 21Gx 1 1/4 Inch, REF 570-2067, 100pcs/box 1000pcs/ctn 350*210*350mm
Product code: FMI Needle, Hypodermic, Single Lumen
Reason for recall: Potential for difficulty in safety mechanism activation.
Root cause tag: manufacturing process
FDA 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.
Distribution: U.S. Nationwide distribution.
Product codes and lots: Lot Numbers / Expiration Date: 20201030 / Exp. Date 2025.10.29, 20201210 / Exp. Date 2025.12.09.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0208-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0204-2022	Class II	Terminated	Voluntary: Firm initiated	2021-11-17	2021-11-05
Z-0205-2022	Class II	Terminated	Voluntary: Firm initiated	2021-11-17	2021-11-05
Z-0206-2022	Class II	Terminated	Voluntary: Firm initiated	2021-11-17	2021-11-05
Z-0207-2022	Class II	Terminated	Voluntary: Firm initiated	2021-11-17	2021-11-05
Z-0208-2022	Class II	Terminated	Voluntary: Firm initiated	2021-11-17	2021-11-05
Z-0209-2022	Class II	Terminated	Voluntary: Firm initiated	2021-11-17	2021-11-05

Product code FMI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)