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U.S. Department of Health and Human Services

Class 2 Device Recall BD Vacutainer Fluoride Tubes for Blood Alcohol determinations

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 Class 2 Device Recall BD Vacutainer Fluoride Tubes for Blood Alcohol determinationssee related information
Date Initiated by FirmMay 30, 2019
Create DateAugust 14, 2019
Recall Status1 Terminated 3 on May 05, 2020
Recall NumberZ-2279-2019
Recall Event ID 83020
Product Classification unknown device name - Product Code N/A
ProductBD Vacutainer Fluoride Tubes for Blood Alcohol determinations Part Number: 367001 Product Usage: Blood Alcohol determinations
Code Information Lot Number: 8187663 Exp. Date: 2020/7/31   UDI: (01)30382903670018 (17)200731(10)8187663 (30)0100
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact
201-847-6800
Manufacturer Reason
for Recall		Lot has been confirmed to have no additive within the tube. Sample processed without the preservative (additive) in the tube, testing has yielded reliable results if the samples were stored at room temperature for no longer than two days. If the sample was stored for more than 2 days, the result for blood alcohol determination might not be accurate (either falsely low or falsely high)
FDA Determined
Cause 2		Process control
ActionBD PAS notified consignees via UPS and email on May 30, 2019. A corrected letter was issued dated June 12, 2019, the sku and lot number for the one affected lot of product was correct, the product name was incorrect. The notice should replace the initially distributed notice dated May 30, 2019. The letter identifies reason for recall, health risk and action to take: 1. Immediately review your inventory for the specific catalog and lot number listed above. Destroy all product subject to the recall in accordance with your institutions process for destruction. 2. Share this Urgent Medical Device Recall notification with all users of the product in your facility to ensure that they are also aware of this recall. 3. Complete the attached Customer Response/Certificate of Destruction Form and return to the BD contact noted on the form regardless of whether you have any affected material or not so that BD may acknowledge your receipt of this notification and process your product replacement, if applicable. Contact: Customer Quality 888-237-2762 OPT 3, OPT 2 Monday  Friday 8:00am and 5:00pm (CT)
Quantity in Commerce247,000 tubes
DistributionUS Nationwide-Distribution in the states of CA, FL, GA, IL, KS, MO, PA, RI, TN Foreign: Canada
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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