FDAClass IIIFebruary 18, 2015

Flyte Togas are components of the Stryker Flyte System recall

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…

Why was Flyte Togas are components of the Stryker Flyte System 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Part/Catalog number: 0408-830-100 Lot number: 11121171 Expiration date (as printed): 2412-12-01

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…
Recalling firm
Stryker Instruments Div. of Stryker Corporation
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.
Recall date
February 18, 2015
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls