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U.S. Department of Health and Human Services

Class 2 Device Recall BD SafetyGlideTM 3ml 25G x 1

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  Class 2 Device Recall BD SafetyGlideTM 3ml 25G x 1 see related information
Date Initiated by Firm July 28, 2020
Create Date August 27, 2020
Recall Status1 Terminated 3 on April 23, 2021
Recall Number Z-2889-2020
Recall Event ID 86120
510(K)Number K951254  
Product Classification Needle, hypodermic, single lumen - Product Code FMI
Product BD SafetyGlideTM 3ml 25G x 1
3mL SafetyGlide syringes, 50 units in pack
Code Information Catalog #: 305924 Lot #: 8289599 UDI #: 30382903059240
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact BD Regulatory Compliance
844-823-5433
Manufacturer Reason
for Recall		 Printed scale markings on the 3mL SafetyGlide syringes, with catalog # 305924, Lot# 8289599, are printed incorrectly. The scale is skewed to different degrees, resulting in missing and/or partially printed scale numbers and scale lines.
FDA Determined
Cause 2		 Equipment maintenance
Action BD Sent a customer letter dated 28 July 2020. this letter requests customers to review their inventory for effected lots and Destroy all product subject to the recall. The letter requests customers to return the included response form and notify BD of any adverse events associated to this product.
Quantity in Commerce 125,200 units
Distribution US and Canada
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.
510(K) Database 510(K)s with Product Code = FMI and Original Applicant = BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
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