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U.S. Department of Health and Human Services

Class 2 Device Recall BD Vacutainer Push Button Blood Collection Set

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 Class 2 Device Recall BD Vacutainer Push Button Blood Collection Setsee related information
Date Initiated by FirmMarch 20, 2018
Create DateApril 26, 2018
Recall Status1 Terminated 3 on April 20, 2020
Recall NumberZ-1531-2018
Recall Event ID 79687
510(K)NumberK030573 
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
ProductBD Vacutainer Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x x 12 (Catalog no 367342)
Code Information 7354908 8005794 8005795 8005796 8010728 8010732 8012784 8012844 8012848 8018509 8019702 
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information ContactZuleika 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
ActionImmediately 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
DistributionUS (Nationwide) Canada, Kuwait, Guyana, Guatemala, Taiwan, UK, Belgium, Sweden, Ireland, Israel, Spain, Switzerland and Lithuania
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JKA
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