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U.S. Department of Health and Human Services

Class 2 Device Recall BD

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  Class 2 Device Recall BD see related information
Date Initiated by Firm December 19, 2014
Date Posted February 05, 2015
Recall Status1 Terminated 3 on December 07, 2015
Recall Number Z-1055-2015
Recall Event ID 70079
510(K)Number K974363  K944931  K110771  
Product Classification Syringe, piston - Product Code FMF
Product BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection ; Catalog #303348,

BD 10 mL Syringe Luer-Lok Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40 mm), not for skin injection; Catalog #305064

BD 10 mL Syringe Luer-Lok Tip with BD Precision Glide Needle 20G x 1 (0.9mm x 25mm); Catalog #305064

Product Usage:
1) BD Blunt Plastic Cannula is used to penetrate pre-slit septums covering injection sites, as well as vials designed for penetration with needless IV access cannula.

2) The blunt steel canula will be targeted for exiting applications of pointer cannula, where blunt steel cannula would provide increased safety. Such existing applications include:
-Accessing pre-slit/pre-pierced IV septum ports
-Providing for fluid transfer
-Can be used as tubing adapter

3) The BD single use Hypodermic Syringe is intended for use by healthcare professional for general purpose fluid aspiration/injection.
Code Information Catalog #303348, Lot #4209518  Catalog #305064, Lot #4205576  Catalog #309644 Lot #4209524
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Ms. Zuleika Sanchez
201-847-6800
Manufacturer Reason
for Recall		 The stopper of the 10mL BD Luer-Lok syringe is not properly seated in the syringe.
FDA Determined
Cause 2		 Device Design
Action BD sent an Urgent Product Advisory Notice letter dated 12/19/2014. The letter identified the affected product, problem and actions to be taken. Customers are advised of the issue with the product and should notify their customers. The attached Product Advisory Response Form should be completed and faxed to 1-866-551-2707. Questions can be directed to 1-866-367-4703.
Quantity in Commerce 564,000 units
Distribution US 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.
510(K) Database 510(K)s with Product Code = FMF and Original Applicant = BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
510(K)s with Product Code = FMF and Original Applicant = Becton, Dickinson and Company
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