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U.S. Department of Health and Human Services

Class 2 Device Recall Vacutainer

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  Class 2 Device Recall Vacutainer see related information
Date Initiated by Firm September 08, 2006
Date Posted December 06, 2006
Recall Status1 Terminated 3 on May 08, 2007
Recall Number Z-0253-2007
Recall Event ID 36585
510(K)Number K991088  
Product Classification Luer-Lok Access Device - Product Code JKA
Product BD Vacutainer Luer-Lok Access Device
Holder with Pre-Attached Multiple Sample Adapter
Sterile, Do Not Reuse, Keep away from heat, Rx only
Ref # 364902
200 (4X50)
BD Franklin Lakes, NJ 07417
Code Information UPC (01)30382903649021  Catalog # 364902 Lot # 6138499 Exp. 4/09 Catalog # 364902 Lot # 6144043 Exp. 4/09 Catalog # 364902 Lot # 6144082 Exp. 4/09 Catalog # 364902 Lot # 6144090 Exp. 4/09 Catalog # 364902 Lot # 6144128 Exp. 4/09 Catalog # 364902 Lot # 6150373 Exp. 4/09 Catalog # 364902 Lot # 6150365 Exp. 5/09 Catalog # 364902 Lot # 6153085 Exp. 5/09 Catalog # 364902 Lot # 6154356 Exp. 5/09 Catalog # 364902 Lot # 6154358 Exp. 5/09 Catalog # 364902 Lot # 6173027 Exp. 5/09 Catalog # 364902 Lot # 6173028 Exp. 5/09 Catalog # 364902 Lot # 6178307 Exp. 5/09 Catalog # 364902 Lot # 6178357 Exp. 5/09
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Michael Malis
201-847-4717
Manufacturer Reason
for Recall		 Reports of failure of the Luer Lok Access Device to lock securely to certain catheter devices because the male luer taper surface is not within the specification.
FDA Determined
Cause 2		 Other
Action Recall notification was sent 9/8/06 to all direct accounts and distributors by US mail, return receipt requested. Consignees were asked to send product back to BD with the packing slip and shipping labels enclosed
Quantity in Commerce 1,744,400
Distribution Worldwide, including USA, Canada, and Australia.
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 VACUTAINER SYSTEMS
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