Recall Z-2259-2024 ยท OEA Non-Surgical Gown
Stryker Corporation
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
| Date | Jul 3, 2024 (initiated Jun 3, 2024) |
| Status | Open, Classified |
| Reason | Expired Products distributed to customers |
| Root cause | Storage |
| Action | 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 s |
| Quantity | 4 units |
| Distribution | US Nationwide distribution in the states of Arkansas, California, Colorado, Florida, Michigan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.