FDA Recall Terminated

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.

Recall: Z-2634-2014 · Initiated June 23, 2014

Recall

Recall Number: Z-2634-2014
Event Number: 68585
Firm: Fresenius Medical Care Holdings, Inc.
FEI Number: 3001451489
Product Code: JKA
Status: Terminated
Root Cause: Storage
Initiated: June 23, 2014
Posted: September 12, 2014
Terminated: January 29, 2021
Address: 920 Winter St, Waltham, MA, 02451-1521

Description

Reason

Products were held at improper storage temperature

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.

Distribution

Distributed in the states of LA, OK, and TX.

Quantity

13 Each