—#173340

Product

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

FDA product code: N/A
Affected lot / code info: Lot Number: 8187663 Exp. Date: 2020/7/31 UDI: (01)30382903670018 (17)200731(10)8187663 (30)0100

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)

Root cause (FDA determination)

Process control

Action the firm took

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)

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: US Nationwide-Distribution in the states of CA, FL, GA, IL, KS, MO, PA, RI, TN Foreign: Canada

Timeline

Recall initiated: 2019-05-30
Terminated: 2020-05-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #173340. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.