| Date Initiated by Firm |
June 03, 2024 |
| Date Posted |
July 03, 2024 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-2259-2024 |
| Recall Event ID |
94755 |
| Product Classification |
Non-surgical gown - Product Code OEA
|
| 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 |
| Code Information |
GTIN: 07613327514063
Lot Number: 20040649 |
Recalling Firm/
Manufacturer |
Stryker Corporation
1941 Stryker Way
Portage MI 49002-9711
|
| For Additional Information Contact |
SAME
269-800-1941
|
Manufacturer Reason
for Recall |
Expired Products distributed to customers
|
FDA Determined
Cause 2 |
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 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. |
| Quantity in Commerce |
4 units |
| Distribution |
US Nationwide distribution in the states of Arkansas, California, Colorado, Florida, Michigan. |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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