FDA recall Z-1461-2024

O&M HALYARD, INC. · Class III · device

Product

HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)

Reason for recall

Product was mislabeled as a Surgical Cap at its dispenser level.

Distribution

Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, HI, MN, MO, MT, SD, TN, TX, and WA. The country of Canada.

Key facts

Status
Ongoing
Initiation date
2024-02-20
Report date
2024-04-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mechanicsville, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1461-2024