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U.S. Department of Health and Human Services

Class 3 Device Recall BD Vacutainer Urine Complete Kit

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  Class 3 Device Recall BD Vacutainer Urine Complete Kit see related information
Date Initiated by Firm October 12, 2009
Date Posted March 08, 2010
Recall Status1 Terminated 3 on March 10, 2010
Recall Number Z-1026-2010
Recall Event ID 53650
510(K)Number K790366  
Product Classification Culture media, non-propagating transport - Product Code JTW
Product BD Vacutainer Urine Complete Kit with UA tube and C&C Preservative Tube for Midstream Specimens. C&S Preservative Boric Acid 6.70mg/ml, Sodium Formate 3.35 mg/ml
PLUS Plastic, Sterile Cup and Tube Interiors. Store at 4-25 degrees C., for In Vitro Diagnostic Use.
Becton Dickinson and Company, Franklin Lakes, NJ;
Kit contains Sterile Screw-Cap Collection Cup and integrated Transfer Device and 10 mL, 16x100 mm Plus Plastic Round Bottom Tube with Preservative for urinalysis and 5.0 mL 16x75mm Glass C&S Preservative Tube and Castile Soap Towelettes.
Code Information Catalog number 364988, lot number 9125270, Exp. 5/2011; lot number 9148024, Exp. 6/2011
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Richard Vales
201-847-5635
Manufacturer Reason
for Recall		 A small amount of discoloration was noted on Towelettes included in BD Vacutainer Urine collection kits. The entire kit components retain sterile interiors and no viable growth was detected on the towelettes.
FDA Determined
Cause 2		 Other
Action Recall notification letters were sent on 10/12/09 with return receipt requested. Customers were advised to contact your SO Sales Consultant for additional information, via e-mail at Vacutainer_TechServices@SD.com or via telephone at 1-800-6310174.
Quantity in Commerce 57150
Distribution Nationwide distribution to hospitals and medical device distributors.
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 = JTW and Original Applicant = BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
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