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U.S. Department of Health and Human Services

Class 2 Device Recall BD Vacutainer PST Tubes (GOLD TOP PST TUBE 3ml)

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  Class 2 Device Recall BD Vacutainer PST Tubes (GOLD TOP PST TUBE 3ml) see related information
Date Initiated by Firm June 23, 2014
Date Posted September 12, 2014
Recall Status1 Terminated 3 on January 29, 2021
Recall Number Z-2634-2014
Recall Event ID 68585
510(K)Number K954592  
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
Product BD Vacutainer PST Tubes (GOLD TOP PST TUBE 3ml)
Part Number: BD 367960
FMC part Number: 87-4544-4

Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use.

The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
Code Information Lot: B011403
Recalling Firm/
Fresenius Medical Care Holdings, Inc.
920 Winter St
Waltham MA 02451-1521
For Additional Information Contact
Manufacturer Reason
for Recall
Products were held at improper storage temperature
FDA Determined
Cause 2
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 13 Each
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 and Original Applicant = BECTON DICKINSON VACUTAINER SYSTEMS