Flyte Togas are components of the Stryker Flyte System and are intended to be worn over any Stryk...
FDA Recall #Z-1077-2015 — Class III — December 22, 2014
Product Description
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).
Reason for Recall
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.
Recalling Firm
Stryker Instruments Div. of Stryker Corporation — Portage, MI
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product 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.
Code Information
Part/Catalog number: 0408-830-100 Lot number: 11121171 Expiration date (as printed): 2412-12-01
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated