HENRY SCHEIN Safety Blood Collection Needle 22Gx 1 1/4 Inch, REF 570-2068, 100pcs/box 1000pcs/ctn 350*210*350mm
Summary
The FDA issued a Class II for HENRY SCHEIN Safety Blood Collection Needle 22Gx 1 1/4 Inch, REF 570-2068, 100pc by Zhejiang Kindly Medical Devices Co., Ltd.. Reason: Potential for difficulty in safety mechanism activation..
Details
Source
Device Recall
External ID
Z-0209-2022
Action Date
2021-11-17
Status
Terminated
Category
device
Product Description
HENRY SCHEIN Safety Blood Collection Needle 22Gx 1 1/4 Inch, REF 570-2068, 100pcs/box 1000pcs/ctn 350*210*350mm
Lot/Code Info: Lot Numbers / Expiration Date: 20201030 / Exp. Date 2025.10.29, 20201210 / Exp. Date 2025.12.09.
Quantity Affected: N/A
Reason for Recall
Potential for difficulty in safety mechanism activation.
Distribution
U.S. Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-24
Company
Wenzhou, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 102 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Zhejiang Kindly Medical Devices Co., Ltd. has 8 FDA actions in our database, including 6 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Zhejiang Kindly Medical Devices Co., Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Zhejiang Kindly Medical Devices Co., Ltd. have FDA actions?
Zhejiang Kindly Medical Devices Co., Ltd. has 8 FDA actions in our database, including 6 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0209-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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