Device product
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).
Z-1077-2015
Product summary
- Event
- Event 70332
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1530 units (170 cases)
- Official record key
device-enforcement:Z-1077-2015
Official wording
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.
Code information: Part/Catalog number: 0408-830-100 Lot number: 11121171 Expiration date (as printed): 2412-12-01
Distribution pattern: Nationwide Distribution including AL, AR, AZ, IA, IL, IN, LA, MA, NC, NE, NM, SC, TN, TX, WI, and WV.
Derived failure modes
-
Unknown
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.