Z-2259-2024 Class II Ongoing
FDA device recall Z-2259-2024 was initiated by Stryker Corporation on Jun 3, 2024 and is designated Class II. Reason for recall: Expired Products distributed to customers The recall status is ongoing. Affected quantity: 4 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 10, 2024
- Initiation Date
- Jun 3, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 units
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
Distribution Pattern
US Nationwide distribution in the states of Arkansas, California, Colorado, Florida, Michigan.
Code Information
GTIN: 07613327514063 Lot Number: 20040649
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2259-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026