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U.S. Department of Health and Human Services

Class 2 Device Recall BD Vacutainer

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  Class 2 Device Recall BD Vacutainer see related information
Date Initiated by Firm November 20, 2007
Date Posted January 23, 2008
Recall Status1 Terminated 3 on September 08, 2008
Recall Number Z-0589-2008
Recall Event ID 45965
510(K)Number K011984  
Product Classification Blood Specimen Collection Device - Product Code JKA
Product BD Vacutainer Push Button Blood collection Sets with Pre-Attached Holder;Catalog Number : 367352: 21G x 3/4" x 12"; 0.8 x 19mm x 305mm, Wingset PBBCS, BD Diagnostics, Franklin Lakes, NJ
Code Information Lot #'s : 7117874, 7157882, 7159943, 7180478, 7215299, 7215300, 7324340, and 7234341.
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact
201-847-7186
Manufacturer Reason
for Recall		 Safety Mechanism Failure: the safety mechanism of the BD Vacutainer Push Button Collection Set with Pre-attached holder cannot be activated; thus the needle cannot retract into the rear barrel.
FDA Determined
Cause 2		 Material/Component Contamination
Action BD sent Recall notification letters, Urgent Class II Product Recall, to customers and distributors on 12/10/07 through a third party, West Inc., Appleton, Wi. Mailings were sent return receipt requested. Letters requested immediate inventory search and product return. Contact number for questions was given as 1-800-631-0174
Quantity in Commerce 105,200 USA; 400 Canada
Distribution Worldwide-USA 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 = JKA and Original Applicant = BECTON DICKINSON & CO.
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