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U.S. Department of Health and Human Services

Class 2 Device Recall BD Vacutainer Push Button Blood Collection Set with 12 in. Tubing

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  Class 2 Device Recall BD Vacutainer Push Button Blood Collection Set with 12 in. Tubing see related information
Date Initiated by Firm August 08, 2016
Create Date December 12, 2016
Recall Status1 Open3, Classified
Recall Number Z-0745-2017
Recall Event ID 75252
510(K)Number K030573  
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
Product BD 23 G x .75 in. BD Vacutainer¿ Push Button Blood
Collection Set with 12 in. Tubing

Catalog # 367342

Intended for venipuncture to obtain blood specimens from patients.
Code Information 5355531 5355533 5356681 5356682 6006629 6006630 6006631 6006633 6006634 6006650  
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Mr. Matthew Kelleher
201-847-6800
Manufacturer Reason
for Recall		 BD has received multiple reports of units associated with the 23 G x .75 in. BD Vacutainer¿ Push Button Blood Collection Set with 12 in. Tubing whose lots are exhibiting separation of front and rear barrels upon activation of the safety feature, which retracts the needle.
FDA Determined
Cause 2		 Device Design
Action The firm, BD, sent a "URGENT PRODUCT RECALL" letter dated 8/8/2016 to its customer with a return response form via UPS 2nd Day mail on 8/8/2016.The letter described the product, problem and actions to be taken. The customers were instructed to immediately review your inventory for the specific lot numbers, quarantine the product and discontinue the shipment of the affected product; complete and return the Recall Response Form by fax to BD at 1-866-913-0661 or email to bd6835@stericycle.com (even if you do not have any product); return all affected products with completed response form per packing instructions; if you have distributed this product, identify your customers and notify them immediately of this product recall; if you would like BD to conduct the notification to your customers, email your customer list within 3 business days to Matthew.Kelleher@bd.com. if you have any questions or require assistance with the return of the recalled product and/or availability of credit product, contact 1-888-628-0732 between 8Am and 5 PM ET Monday through Friday.
Quantity in Commerce 1,788,150 units
Distribution Worldwide distribution- US (nationwide) and countries of: Canada, Belgium, Brazil.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JKA and Original Applicant = BD VACUTAINER SYSTEMS PREANALYICAL SOLUTIONS
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