FDA-Device2024-04-10Class III

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

O&M HALYARD, INC.
Hazard

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

Sold states
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.
Affected count
250 cases (75,000 pieces)
Manufactured in
9120 Lockwood Blvd, Mechanicsville, VA, United States
Products
HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)

Official notice

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

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