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U.S. Department of Health and Human Services

Class 2 Device Recall BD Probetec" ET CT/GC Endocervical Specimen Collection and Dry Transport SystemPink Cap

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  Class 2 Device Recall BD Probetec" ET CT/GC Endocervical Specimen Collection and Dry Transport SystemPink Cap see related information
Date Initiated by Firm September 18, 2009
Date Posted March 03, 2010
Recall Status1 Terminated 3 on March 24, 2010
Recall Number Z-0969-2010
Recall Event ID 54152
Product Classification DNA-reagents, neisseria - Product Code MKZ
Product BD Probetec" ET CT/GC Endocervical Specimen Collection and Dry Transport System-Pink Cap, Catalog number 440476, packed in shelfpack unit of 100 swabs.
Code Information Lot 7016132, Exp date 01/17/09.
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
7 Loveton Cir
Sparks MD 21152-9212
For Additional Information Contact Kimberly Cartier
800-638-8663
Manufacturer Reason
for Recall		 Product was shipped beyond its expiration date.
FDA Determined
Cause 2		 Employee error
Action The recalling firm notified end users by letter flagged as "Urgent Product Recall" on 09/18/09. The notification advised that the referenced lot number had been correctly labeled with expiration date but had been shipped after the labeled date. End users were instructed to discontinue use discard product for replacement and return enclosed response form. If further assistance is needed regarding replacements, please contact SD Customer Service Department at 1-800-675-0908. For all other inquiries, please contact SD Technical Services Department at 1-800-638-8663.
Quantity in Commerce 242 packs
Distribution The product was sold for distribution to clinical laboratories nationwide and to the firm's international affiliate in 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.
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