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
Recall
- Recall Number
- Z-2259-2024
- Event Number
- 94755
- Firm
- Stryker Corporation
- FEI Number
- 3015967359
- Product Code
- OEA
- Status
- Open, Classified
- Root Cause
- Storage
- Initiated
- June 3, 2024
- Posted
- July 3, 2024
- Address
- 1941 Stryker Way, Portage, MI, 49002-9711
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
Expired Products distributed to customers
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 [email protected], 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 [email protected] with questions or concerns.
US Nationwide distribution in the states of Arkansas, California, Colorado, Florida, Michigan.
4 units