—#152720

Product

BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (4.5 ml x 13 x 75 mm) Catalog Number: 369714 Product Usage: The BD Vacutainer Safety Coagulation tube is an evacuated blood collection tube that provides means of collecting, transporting and processing blood in a closed tube. The buffered sodium citrate additive provides an anti-coagulated specimen that may be used for clinical laboratory coagulation assays and determinations

FDA product code: JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K945952
Affected lot / code info: Lot 6090572

Why it was recalled

A portion of this lot of blood collection tubes was manufactured with approximately twice the expected amount of buffered sodium citrate additive, an anticoagulant.

Root cause (FDA determination)

Process control

Action the firm took

BD sent an Urgent Product Recall letter dated January 16, 2017 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the Customer Recall Response Form and fax the completed form back to BD at 1-844-388-5534 or email the completed form to bd8872@stericycle.com. For questions call 1-844-265-7408.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - US Nationwide and the countries of Canada, Mexico, Indonesia

Timeline

Recall initiated: 2017-01-16
Terminated: 2018-02-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #152720. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.