Device recall

Z-0767-2017: IVEA 500A Intended for Med-Surg patient care.

FDA device recall · Class II · Firefly Medical, Inc.

Key facts

Recall number (Z-number) Z-0767-2017
Recall event 75571
Product IVEA 500A Intended for Med-Surg patient care.
Product code FOX
Recalling firm Firefly Medical, Inc.
Recall class Class II
Status Terminated
Termination date Aug 1, 2017
FEI number 3011390406

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 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

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