Class 2 Device Recall BD Vacutainer EDTA Tubes (LAVENDER TOP TUBE 2.0ML)

• Date Initiated by Firm: June 23, 2014
• Date Posted: September 12, 2014
• Recall Status: Terminated on January 29, 2021
• Recall Number: Z-2630-2014
• Recall Event ID: 68585
• 510(K)Number: K921806
• Product Classification: Tubes, vials, systems, serum separators, blood collection - Product Code JKA
• Product: BD Vacutainer EDTA Tubes (LAVENDER TOP TUBE 2.0ML) Part Number: BD 367841 Part Number: FMC 87-7841-7 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use.
• Code Information: Lot: 3343067
• Recalling Firm/ Manufacturer: Fresenius Medical Care Holdings, Inc.; 920 Winter St; Waltham MA 02451-1521
• For Additional Information Contact: 800-662-1237
• Manufacturer Reason for Recall: Products were held at improper storage temperature
• FDA Determined Cause: Storage
• Action: Fresenius Medical North America contacted customers via telephone on 6/23/14 by Customer Service and follow-up with formal letter notification, Urgent Recall by certified mail with signature confirmation and fax-back form. Customers instructed to examine their inventory to determine whether they have any of the affected Naturalyte Liquid Bicarbonate or BD Collection Tubes. If customers have the affected product, they will be instructed to contact FMC-RTG Customer Service to have the product replaced. On July 10, 2014 Fresenius issued a clarification letter to users to state only products from the identified lots that were delivered by RTG LLC to the specified facilities on May 5, 2014 are affected by this recall as the products were exposure to higher temperatures than recommended. If you have any additional questions, please contact your FMCNA Customer Service Team at 1-800-323-5188.
• Quantity in Commerce: 26 boxes
• Distribution: Distributed in the states of LA, OK, and TX.
• 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