Class 2 Device Recall BD Vacutainer Blood Collection Tubes

• Date Initiated by Firm: June 12, 2019
• Create Date: August 21, 2019
• Recall Status: Terminated on June 29, 2020
• Recall Number: Z-2305-2019
• Recall Event ID: 82963
• 510(K)Number: K945952
• Product Classification: Tubes, vials, systems, serum separators, blood collection - Product Code JKA
• Product: BD Vacutainer PST Gel and Lithium HeparinN (LH) 126 Units Blood Collection Tubes, Catalog Number 367964
• Code Information: UDI: (01)30382903679646
• Recalling Firm/ Manufacturer: Becton Dickinson & Company; 1 Becton Dr; Franklin Lakes NJ 07417-1815
• For Additional Information Contact: Customer Quality; 888-237-2762
• Manufacturer Reason for Recall: False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.
• FDA Determined Cause: Device Design
• Action: Urgent Medical Device Correction notification letters dated 6/12/19 were sent to customers.
• Quantity in Commerce: 1,436,228,004 total
• Distribution: Worldwide Distribution, including US Nationwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JKA