The Non-Sterile Flyte hood covers the user s head and neck region and is intended to be worn with...
FDA Recall #Z-2259-2024 — Class II — June 3, 2024
Product Description
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
Recalling Firm
Stryker Corporation — Portage, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
4 units
Distribution
US Nationwide distribution in the states of Arkansas, California, Colorado, Florida, Michigan.
Code Information
GTIN: 07613327514063 Lot Number: 20040649
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated