BD Vacutainer Fluoride Tubes for Blood Alcohol… recallZ-2279-2019 · Becton Dickinson & Company · initiated May 30, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Becton Dickinson & Company or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Process control
What the company is doing
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)
Recall details
- Recall number
- Z-2279-2019
- Status
- Terminated
- Initiated by the company
- May 30, 2019
- Recalling firm
- Becton Dickinson & Company
- Quantity
- 247,000 tubes
- Product code
- N/A
- Distribution
- US Nationwide-Distribution in the states of CA, FL, GA, IL, KS, MO, PA, RI, TN Foreign: Canada
Product description
BD Vacutainer Fluoride Tubes for Blood Alcohol determinations Part Number: 367001 Product Usage: Blood Alcohol determinations
Code information (models, lots, serial numbers)
Lot Number: 8187663 Exp. Date: 2020/7/31 UDI: (01)30382903670018 (17)200731(10)8187663 (30)0100
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BD Vacutainer® Blood Alcohol Determinations Tube 367001Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection2 recalls51 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page