Date Initiated by Firm |
June 12, 2019 |
Create Date |
August 21, 2019 |
Recall Status1 |
Terminated 3 on June 29, 2020 |
Recall Number |
Z-2308-2019 |
Recall Event ID |
82963 |
510(K)Number |
K945952
|
Product Classification |
Tubes, vials, systems, serum separators, blood collection - Product Code JKA
|
Product |
BD Vacutainer LH (Lithium Heparin) 34 I.U. Plus Blood Collection Tubes, Catalog Number 368494 |
Code Information |
UDI: (01)30382903680352 |
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 2 |
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
|
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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 and Original Applicant = BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
|