Recall Z-1504-2018 ยท FYA Gown, Surgical
Stryker Instruments Div. of Stryker Corporation
T4 Pullover Toga, X-Large; Catalog Number: 0400-770-000 Sterile personal protection garment
| Date | Feb 23, 2018 |
| Status | Terminated |
| Reason | Separation of material layers may occur, causing a potential risk of exposure to contaminants. |
| Root cause | Nonconforming Material/Component |
| Action | On March 7, 2018 Stryker Instruments mailed Urgent Medical Device Recall Notifications to affected customers. Distributors and Sales Representative were notified via e-mail. Customers were instructed to: 1) Immediately review this Recall Notification; 2) Immediately check all stock areas and/or operating room storage for affected products. Quarantine and discontinue use of any affected T4 and T5 Togas; 3) Complete the enclosed Business Reply Form (BRF) to confirm receipt of this Notification and identify how many affected items are currently in your inventory. Please complete and return th |
| Quantity | 34570 total products |
| Distribution | US Nationwide and Ireland, Japan, South Korea, UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070078 | STRYKER T4 HYTREL TOGA Stryker Instruments, Instruments Div., Feb 2, 2007 |