Recall Z-1077-2015 ยท FYA Gown, Surgical
Stryker Instruments Div. of Stryker Corporation
Flyte Togas are components of the Stryker Flyte System and are intended to be worn over any Stryker Flyte Helmet. This toga provides Level 1 and 4 protection according to the Association for the Advancement of Medical Instrumentation (AAMI) Liquid Barrier Performance and Classification System (PB70:2012).
| Date | Feb 10, 2015 (initiated Dec 22, 2014) |
| Status | Terminated |
| Reason | A single lot (11121171) of Flyte Toga Peel-away X-Large (catalog number 0408-830-100) was labeled with an incorrect expiration date of 2412-12-01. The correct expiration date should have read 2014-12-01. |
| Root cause | Error in labeling |
| Action | Stryker sent an Urgent Medical Device Recall Notification letter dated December 22, 2014, to all affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and responding to the formal recall notification. Customers were instructed to do the following: 1. Immediately review this Recall Notification 2. Immediately check all stock areas and/or operating room storage and quarantine any affected product found. 3. Complete the enclosed Business Reply Form (BRF) to confirm receipt of this notification and identify |
| Quantity | 1530 units (170 cases) |
| Distribution | Nationwide Distribution including AL, AR, AZ, IA, IL, IN, LA, MA, NC, NE, NM, SC, TN, TX, WI, and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073017 | STRYKER STRI-SHIELD FLYTE TOGAS Stryker Instruments, Instruments Div., Nov 30, 2007 |