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U.S. Department of Health and Human Services

Class 2 Device Recall BD Vacutainer Ultra TouchTM Push Button Blood Collection Set

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  Class 2 Device Recall BD Vacutainer Ultra TouchTM Push Button Blood Collection Set see related information
Date Initiated by Firm March 20, 2018
Create Date April 26, 2018
Recall Status1 Terminated 3 on April 20, 2020
Recall Number Z-1533-2018
Recall Event ID 79687
510(K)Number K030573  
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
Product BD Vacutainer¿ Ultra TouchTM Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿ x 12. Catalog no 367364
Code Information 7348980
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Zuleika Sanchez
201-847-6800
Manufacturer Reason
for Recall		 Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.
FDA Determined
Cause 2		 Material/Component Contamination
Action Immediately review your inventory for the specific Catalog (Ref) and lot numbers, and quarantine product subject to the recall. Immediately discontinue the distribution of the affected product. If you have inventory of the recalled product, please complete the attached Business Response Form and return the recalled product following the enclosed packing instruction. This is required so that BD may process your product replacement. If you do not have the recalled product, please complete the attached Business Response Form as well so that BD receives an acknowledgement of your receipt of this recall notification
Distribution US (Nationwide) Canada, Kuwait, Guyana, Guatemala, Taiwan, UK, Belgium, Sweden, Ireland, Israel, Spain, Switzerland and Lithuania
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 = JKA and Original Applicant = BD VACUTAINER SYSTEMS PREANALYICAL SOLUTIONS
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