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Recall Observatory FDA recall evidence

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

June 03, 2024

Class II

Product summary

Firm
Stryker Corporation
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

    reason.no_named_rule · v1.0.0

    Expired Products distributed to customers