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U.S. Department of Health and Human Services

Class 2 Device Recall BD Vacutainer Push Button Blood Collection Set

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 Class 2 Device Recall BD Vacutainer Push Button Blood Collection Setsee related information
Date Initiated by FirmJuly 31, 2019
Create DateOctober 24, 2019
Recall Status1 Terminated 3 on July 27, 2020
Recall NumberZ-0193-2020
Recall Event ID 83507
510(K)NumberK011984 
Product Classification Needle, hypodermic, single lumen - Product Code FMI
ProductBD Vacutainer Push Button Blood Collection Set with Pre-Attached Holder Catalog number 368356 - Product Usage: This product is designed to provide customers an increased level of safety during IV blood collection, convenience and to improve OSHA single-use holder compliance. Figure 1 shows a BD Vacutainer Push Button Blood Collection Set with the needle protector removed prior to needle retraction.
Code Information Lot / Serial Number. 9079767 9079770 9081829 9086811 9086812 9091607 9091626 9094659 9094661 9098547 9100711 9100712 9115965 9115913 
FEI Number 2243072
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information ContactMs. Gail Griffiths
410-316-4054
Manufacturer Reason
for Recall		Separation of front and rear barrels upon activation of the safety feature that retracts the needle
FDA Determined
Cause 2		Under Investigation by firm
Action1. Immediately review your inventory for Catalog# 368656 with the lot numbers listed. Return all product subject to recall according to the Packing Instructions enclosed. 2. Identify all your customers that purchased affected lots of Catalog #368656, as listed . E-mail an excel file listing of all customers with their email addresses to BD6086@stericycle.com, within 72 hours of receipt of this letter so that BD may notify these customers directly. 3. Complete the attached Distributor Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification and process your credit accordingly. Please note that this is in addition to providing the customer list For any question please contact Customer/Technical Support: 888-237-2762 OPT 3, OPT 2; Monday  Friday 8:00am - 5:00pm (CT)
Quantity in Commerce1735600 units
DistributionWorldwide distribution - US Nationwide distribution including the states of CT, FL, MO, TN, OH, TX, GA, NC, SC, IN, IL, PA, CO and countries of Trinidad and Tobago, Hong Kong.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FMI
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