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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = JTW
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