Date Initiated by Firm | November 12, 2012 |
Create Date | June 26, 2015 |
Recall Status1 |
Terminated 3 on September 06, 2013 |
Recall Number | Z-0756-2013 |
Recall Event ID |
64010 |
510(K)Number | K013971 |
Product Classification |
Tubes, vials, systems, serum separators, blood - Product Code JKA
|
Product | BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Sterile; IVD; REF 363083; 13 X 75 mm, 2.7 mL |
Code Information |
Lot No. 2180434; Expiration Date: April 2013 |
Recalling Firm/ Manufacturer |
Becton Dickinson & Company 1 Becton Dr Franklin Lakes NJ 07417-1815
|
For Additional Information Contact | Yogindra Dellow 201-847-5033 |
Manufacturer Reason for Recall | BD is conducting a recall of the BD Vacutainer 2.7mL Plus Citrate Blood Collection Tube due to extended Partial Thromboplastin Time (aPTT) test results reported in two customer complaints. |
FDA Determined Cause 2 | Material/Component Contamination |
Action | BD sent "ATTENTION: PRODUCT RECALL" letters dated November 12, 2012 via UPS to distributors and customers instructing them to examine their inventory immediately and discontinue the shipment of the affected product. All customers were instructed to return all products from the lot affected, by following the instructions on the enclosed packing slip,and BD will send them replacement products at no charge. Contact the firm at 10201-847-4267 for assistance. |
Quantity in Commerce | 2,944,700 units |
Distribution | Worldwide Distribution-USA (nationwide) and the countries of Canada, India, Japan, Nepal, Malaysia, Singapore, Brazil, Costa Rica, and Virgin Islands. |
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
|