Device recall

Z-3182-2024: HAWK Advanced Hypothermia Management Set, Item Number: 59-320

FDA device recall · Class II · Safeguard US Operating LLC

Key facts

Recall number (Z-number) Z-3182-2024
Recall event 95183
Product HAWK Advanced Hypothermia Management Set, Item Number: 59-320
Product code IMD
Recalling firm Safeguard US Operating LLC
Recall class Class II
Status Open, Classified
FEI number 3008258694

At a glance

  • None Linked 510(k)s
  • 1–9 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)