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U.S. Department of Health and Human Services

Class 2 Device Recall Vacutainer

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  Class 2 Device Recall Vacutainer see related information
Date Initiated by Firm August 29, 2017
Create Date March 12, 2018
Recall Status1 Terminated 3 on May 16, 2019
Recall Number Z-0968-2018
Recall Event ID 79041
510(K)Number BK050036  K981013  
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
Product BD Vacutainer¿ K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841.

Used for whole blood hematology determinations, immunohematology testing and blood donor screening.
Code Information Catalog No. 367841 Lot No. 6279849 UDI: (01)30382903678410
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact
201-847-6800
Manufacturer Reason
for Recall		 A limited portion of the lot was manufactured with less than the required amount of K2EDTA additive, an anticoagulant, which may cause erroneous results that could lead to specimen recollection and potential delay of treatment or misdiagnosis/mismanagement of treatment and serious complications, such as failure to detect thrombocytosis or postponing surgery.
FDA Determined
Cause 2		 Under Investigation by firm
Action In August of 2017 All US direct consignees were contacted via e-mail and/or UPS mail. An Urgent Product Removal Recall letter was issued, identifying the affected device and the reason for the recall. It also requested customers to review their inventory and quarantine any affected devices, which will be returned to the firm for replacement. The Customer Recall Response Form should be completed and returned regardless of whether there is any affected devices on hand. For questions or concerns please contact Customer Service at 1-855-215-4992.
Quantity in Commerce 8,494,000
Distribution Nationwide Distribution
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 and Original Applicant = BECTON DICKINSON VACUTAINER SYSTEMS
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