Stryker Instruments Div. of Stryker Corporation recalls Flyte Togas are components of the Stryker Flyte System and are intended to be worn over any Stryker Flyte Helmet. This…

Recall date

December 22, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1077-2015

FDA classification

Class III

Brand / firm

Stryker Instruments Div. of Stryker Corporation

Sold / distributed

Nationwide Distribution including AL, AR, AZ, IA, IL, IN, LA, MA, NC, NE, NM, SC, TN, TX, WI, and WV.

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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).