—#208193

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

FDA product code: OEA — Non-Surgical Gown
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: GTIN: 07613327514063 Lot Number: 20040649

Why it was recalled

Expired Products distributed to customers

Root cause (FDA determination)

Storage

Action the firm took

Stryker issued Urgent Medical Device Recall Letter on 6/3/24 via Fed'X. Letter states reason for recall, health risk and action to take: Actions to be taken: 1. Immediately check your inventory to locate and quarantine any affected products found at your facility. 2. Sign and return the enclosed Business Response Form (BRF) by email to Instruments.recalls@stryker.com, even if affected product is no longer in your inventory. 3. Upon receipt of the completed BRF, a shipping label will be provided to return any recalled product on-hand and Stryker will arrange for replacement product(s) to be shipped promptly. 4. Maintain awareness of this communication internally and inform Stryker if any of the devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients accordingly. Please contact Lacey Marshall at 269-270-5950 or Instruments.recalls@stryker.com with questions or concerns.

Recalling firm

Firm: Stryker Corporation
Address: 1941 Stryker Way, Portage, Michigan 49002-9711

Distribution

Distribution pattern: US Nationwide distribution in the states of Arkansas, California, Colorado, Florida, Michigan.

Timeline

Recall initiated: 2024-06-03
Posted by FDA: 2024-07-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #208193. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.