Skip to content

Serum Blood Collection Tubes recallZ-0086-06 · Greiner VACUETTE North America · initiated Jul 28, 2005

Terminated All recalls posted in October 2005

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 Greiner VACUETTE North America 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

Serum Blood Collection tubes found with excess of Blood Clot Accelerator (BCA) solution.

FDA root cause category: Other

What the company is doing

Consignees were notified by letter on 07/28/2005.

Recall details

Recall number
Z-0086-06
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jul 28, 2005
Posted by the FDA
Oct 22, 2005
Recalling firm
Greiner VACUETTE North America
Quantity
1623 cases (1,947,600 pieces)
Product code
JKA
FDA submissions
K960858
Distribution
Nationwide, Chile, Costa Rica, Ecuador, El Salvador, Nicaragua and Uruguay.

Product description

Serum Blood Collection Tubes

Code information (models, lots, serial numbers)

Item #455071, Lot #B040513 and Item #455092, Lot #B040503

Other devices under the same FDA submission

4 devices cleared under K960858 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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