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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-0590-2008
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: 368656; 23 g X12 " PBBCS w/PAH (Preattached), BD Diagnostics, Franklin Lakes, NJ
Code Information Lot #'s: 6090251R, 6094839, 6111757R, 6121669, 6121676, 6138669, 6146186R, 6152710, 6151443, 6160625, 6164839, 6171015, 6174156, 6178381, 7018205, 7025868, 7026017, 7033728, 7093399, 7093400, 7093403, 7106969, 7106970, 7106971, 7106972, 7113647, 7113648, 7124156, 7124157, 7131786, 7141678, 7141679, 7141680, 7150272, 7162775, 7167155, 7169403, 7172215, 7177261, and 7208536.
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 769,200 USA; 1,300 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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