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U.S. Department of Health and Human Services

Class 2 Device Recall Henry Schein Safety Blood Collection Needle

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  Class 2 Device Recall Henry Schein Safety Blood Collection Needle see related information
Date Initiated by Firm August 24, 2021
Create Date November 05, 2021
Recall Status1 Terminated 3 on July 21, 2023
Recall Number Z-0208-2022
Recall Event ID 88757
Product Classification Needle, hypodermic, single lumen - Product Code FMI
Product HENRY SCHEIN Safety Blood Collection Needle 21Gx 1 1/4 Inch, REF 570-2067, 100pcs/box 1000pcs/ctn 350*210*350mm
Code Information Lot Numbers / Expiration Date: 20201030 / Exp. Date 2025.10.29, 20201210 / Exp. Date 2025.12.09.
Recalling Firm/
Manufacturer		 Zhejiang Kindly Medical Devices Co., Ltd.
# 758 Binghai Five Rd.
Longwan Dist
Wenzhou China
For Additional Information Contact
8657708687200
Manufacturer Reason
for Recall		 Potential for difficulty in safety mechanism activation.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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