FDA recall Z-2259-2024

Stryker Corporation · Class II · device

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

Reason for recall

Expired Products distributed to customers

Distribution

US Nationwide distribution in the states of Arkansas, California, Colorado, Florida, Michigan.

Key facts

Status
Ongoing
Initiation date
2024-06-03
Report date
2024-07-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Portage, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2259-2024