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
Z-2259-2024
Product summary
- Event
- Event 94755
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4 units
- Official record key
device-enforcement:Z-2259-2024
Official wording
Reason: Expired Products distributed to customers
Code information: GTIN: 07613327514063 Lot Number: 20040649
Distribution pattern: US Nationwide distribution in the states of Arkansas, California, Colorado, Florida, Michigan.
Derived failure modes
-
Unknown
Expired Products distributed to customers