| Class 2 Device Recall 3mL SafetyLok Syringe | |
Date Initiated by Firm | February 01, 2019 |
Create Date | July 22, 2019 |
Recall Status1 |
Terminated 3 on June 11, 2020 |
Recall Number | Z-2008-2019 |
Recall Event ID |
82138 |
510(K)Number | K944757 |
Product Classification |
Needle, hypodermic, single lumen - Product Code FMI
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Product | 3mL Safety-Lok Syringe, Catalog Number 309606, UDI 30382903096061 |
Code Information |
Lot Number 8307694 |
Recalling Firm/ Manufacturer |
Becton Dickinson & Company 1 Becton Dr Franklin Lakes NJ 07417-1815
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Manufacturer Reason for Recall | The syringes have scale markings that were printed incorrectly. The scale is skewed to varying degrees, resulting in missing and/or partially printed scale numbers and scale lines. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | Urgent Medical Device Recall notification letters dated 2/1/19 were sent to customers. |
Quantity in Commerce | 428,800 |
Distribution | The products were distributed to the following US states: FL, IL, KS, MA, ND, NH, NY, OH, PA, RI, SC, VA, and WI.
The products were distributed to the following foreign countries: Suriname. |
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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