Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-3182-2024

August 27, 2024

Class II

Product summary

Firm
Safeguard US Operating LLC
Event
Event 95183
Status
Ongoing
Classification
Class II
Quantity
408 units
Official record key
device-enforcement:Z-3182-2024

Official wording

Reason: Incorrect expiration date.

Code information: Item Number: 59-320; Lot Numbers: PBO0003797, PBO0003811, PBO0004032, PBO0004315, PBO0004580.

Distribution pattern: US Nationwide distribution in the states of AK, CA, CO, DC, GA, IL, NC, NM, NY, OK, OR, RI, TX, VA, WA, WI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Incorrect expiration date.