Home / Recalls / Medical Devices
Stryker Corporation recalls The Non-Sterile Flyte hood covers the user s head and neck region and is intended to be worn with commercially available
Recalled July 10, 2024 · FDA recall Z-2259-2024 · Stryker
Hazard
Expired Products distributed to customers · FDA Class II
Units
4 units
Sold at
US Nationwide distribution in the states of Arkansas, California, Colorado, Florida, Michigan.
Description
Expired Products distributed to customers
Product
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
Manufacturer(s)
Stryker Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →