FDA recall Z-3182-2024

Safeguard US Operating LLC · Class II · device

Product

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

Reason for recall

Incorrect expiration date.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2024-08-27
Report date
2024-09-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Harrisburg, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3182-2024