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Recall Observatory FDA recall evidence

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

December 22, 2014

Class III

Product summary

Firm
Stryker Instruments Div. of Stryker Corporation
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

    reason.no_named_rule · v1.0.0

    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.