Date Initiated by Firm | September 16, 2016 |
Create Date | July 19, 2017 |
Recall Status1 |
Terminated 3 on March 20, 2018 |
Recall Number | Z-2748-2017 |
Recall Event ID |
77513 |
510(K)Number | K951254 |
Product Classification |
Needle, hypodermic, single lumen - Product Code FMI
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Product | BD SafetyGlide" Injection Needle
Catalog #305917
The SafetyGlide " needle is intended to be used for general purpose injection, aspiration of fluids from parts of the body below the surface of the skin, injection into intravenous ports and tubings external to the patient. The needlestick prevention feature of the device contains a mechanism that covers the needlepoint after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used needle/syringe combination |
Code Information |
6022838 2021-01 |
Recalling Firm/ Manufacturer |
Becton Dickinson & Company 1 Becton Dr Franklin Lakes NJ 07417-1815
|
For Additional Information Contact | 201-847-6800 |
Manufacturer Reason for Recall | BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required. |
FDA Determined Cause 2 | Process control |
Action | BD sent recall letter/return response form on 9/16/2016. |
Quantity in Commerce | 29,500 units |
Distribution | Nationwide Distribution |
Total Product Life Cycle | TPLC Device Report |
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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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510(K) Database | 510(K)s with Product Code = FMI
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