Z-2279-2019Class II

BD Vacutainer Fluoride Tubes for Blood Alcohol determinations Part Number: 367001

Name: Z-2279-2019 BD Vacutainer Fluoride Tubes for Blood Alcohol determinations Part Number: 367001
Creator: Becton Dickinson & Company
Published: 2019-05-30
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2019-05-30 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Company began a recall of BD Vacutainer Fluoride Tubes for Blood Alcohol determinations Part Number: 367001 Product Usage: Blood Alcohol determinations on 2019-05-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2279-2019
Classification: Class II
Status: Terminated
Initiated: 2019-05-30
Posted: 2019-08-14
Terminated: 2020-05-05
Recalling firm: Becton Dickinson & Co
Product: BD Vacutainer Fluoride Tubes for Blood Alcohol determinations Part Number: 367001 Product Usage: Blood Alcohol determinations
Product code: N/A
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)
Root cause tag: manufacturing process
FDA root cause: Process control
Action: BD 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 commerce: 247,000 tubes
Distribution: US Nationwide-Distribution in the states of CA, FL, GA, IL, KS, MO, PA, RI, TN Foreign: Canada
Product codes and lots: Lot Number: 8187663 Exp. Date: 2020/7/31 UDI: (01)30382903670018 (17)200731(10)8187663 (30)0100

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2279-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2279-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-14

Product code N/A

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)