Date Initiated by Firm | January 16, 2017 |
Create Date | February 10, 2017 |
Recall Status1 |
Terminated 3 on February 07, 2018 |
Recall Number | Z-1189-2017 |
Recall Event ID |
76295 |
510(K)Number | K945952 |
Product Classification |
Tubes, vials, systems, serum separators, blood collection - Product Code JKA
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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 |
Code Information |
Lot 6090572 |
Recalling Firm/ Manufacturer |
Becton Dickinson & Company 1 Becton Dr Franklin Lakes NJ 07417-1815
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For Additional Information Contact | Mr. Matthew Kelleher 201-847-6800 |
Manufacturer Reason for Recall | A portion of this lot of blood collection tubes was manufactured with approximately twice the expected amount of buffered sodium citrate additive, an anticoagulant. |
FDA Determined Cause 2 | Process control |
Action | 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. |
Quantity in Commerce | 1,488,800 tubes |
Distribution | Worldwide Distribution - US Nationwide and the countries of Canada, Mexico, Indonesia |
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.
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510(K) Database | 510(K)s with Product Code = JKA
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