FDA-Device2024-07-10Class II
The Non-Sterile Flyte hood covers the user s head and neck region and is intended to be worn with commercially available gowns. The hood is donned after the Flyte helmet and before the gown, such that the hood is securely tucked inside the gown. The hood attaches to and covers the helmet and air is drawn into the helmet through a filter located on the top-backside of the hood. The filtered air is delivered into the helmet and the disposable does not inhibit adjustment of helmet settings/function
Stryker Corporation
Hazard
Expired Products distributed to customers
Sold states
US Nationwide distribution in the states of Arkansas, California, Colorado, Florida, Michigan.
Affected count
4 units
Manufactured in
1941 Stryker Way, N/A, Portage, MI, United States
Products
The Non-Sterile Flyte hood covers the user s head and neck region and is intended to be worn with commercially available gowns. The hood is donned after the Flyte helmet and before the gown, such that the hood is securely tucked inside the gown. The hood attaches to and covers the helmet and air is drawn into the helmet through a filter located on the top-backside of the hood. The filtered air is delivered into the helmet and the disposable does not inhibit adjustment of helmet settings/functions. Catalog Number: 0408-800-000NS
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2259-2024Don't want to check this manually?
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