FDAFDA · Food and drugs·Recall number Z-2259-2024
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
Published July 10, 2024 · Recall initiated: June 3, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Expired Products distributed to customers
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Corporation
- Distributor
- US Nationwide distribution in the states of Arkansas, California, Colorado, Florida, Michigan.
- Lot
- GTIN: 07613327514063 Lot Number: 20040649
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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