Device recall

Z-0571-2026: Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator…

FDA device recall · Class II · Greiner Bio-One North America, Inc.

Key facts

Recall number (Z-number) Z-0571-2026
Recall event 97499
Product Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner VACUETTE Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8ml)
Product code JKA
Recalling firm Greiner Bio-One North America, Inc.
Recall class Class II
Status Open, Classified
510(k) numbers K081929
FEI number 3001451379

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)