HAWK Advanced Hypothermia Management Set, Item Number: 59-320
FDA Recall #Z-3182-2024 — Class II — August 27, 2024
Product Description
HAWK Advanced Hypothermia Management Set, Item Number: 59-320
Reason for Recall
Incorrect expiration date.
Recalling Firm
Safeguard US Operating LLC — Harrisburg, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
408 units
Distribution
US Nationwide distribution in the states of AK, CA, CO, DC, GA, IL, NC, NM, NY, OK, OR, RI, TX, VA, WA, WI.
Code Information
Item Number: 59-320; Lot Numbers: PBO0003797, PBO0003811, PBO0004032, PBO0004315, PBO0004580.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated