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BD Vacutainer Citrate Tubes (LIGHT BLUE TOP TUBE 2.7ML)Part… recallZ-2633-2014 · Fresenius Medical Care Holdings, Inc. · initiated Jun 23, 2014

Class II Terminated All recalls posted in September 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Fresenius Medical Care Holdings, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Products were held at improper storage temperature

FDA root cause category: Storage

What the company is doing

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.

Recall details

Recall number
Z-2633-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Jun 23, 2014
Posted by the FDA
Sep 12, 2014
Recalling firm
Fresenius Medical Care Holdings, Inc.
Quantity
2 each
Product code
JKA
FDA submissions
K013971
Distribution
Distributed in the states of LA, OK, and TX.

Product description

BD Vacutainer Citrate Tubes (LIGHT BLUE TOP TUBE 2.7ML)Part number: BD 363083 Part Number: FMC 87-3083-8 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. Coagulation studies.

Code information (models, lots, serial numbers)

Lot: 4007362

Other devices under the same FDA submission

7 devices cleared under K013971 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 68585).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page