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BD Vacutainer Fluoride Tubes for Blood Alcohol… recallZ-2279-2019 · Becton Dickinson & Company · initiated May 30, 2019

Terminated

Is my device affected?

  1. 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.
  2. 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.
  3. 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.

Sources and updates

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