Device recall

Z-2145-2010: Exacta-Mix Calibration Bag, Sterile R, non-pyrogenic fluid path, 250 mL Reorder…

FDA device recall · Class II · Baxa Corporation

Key facts

Recall number (Z-number) Z-2145-2010
Recall event 55931
Product Exacta-Mix Calibration Bag, Sterile R, non-pyrogenic fluid path, 250 mL Reorder No. H938 371 3, Manufactured for Baxa Corporation.
Product code KPE
Recalling firm Baxa Corporation
Recall class Class II
Status Terminated
Termination date Aug 4, 2011
510(k) numbers K900585
FEI number 1419106

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 Products in the same recall event
  • 10–99 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)