Stryker Flyte Toga Recall Due to Incorrect Expiration Date Labeling
Stryker is recalling Flyte Togas with an incorrect expiration date. The label reads 2412-12-01 instead of 2014-12-01.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III and involves a documentation/labeling error (incorrect expiration date) without reported injuries or illnesses, fitting the 'Low' severity criteria for packaging or documentation issues.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling a single lot of Flyte Toga Peel-away X-Large (catalog number 0408-830-100). The product is a component of the Stryker Flyte System intended to be worn over Stryker Flyte Helmets to provide liquid barrier protection.
The recall is due to a labeling error where the expiration date was printed as 2412-12-01. The correct expiration date for this lot is 2014-12-01. The affected lot number is 11121171.
A total of 1,530 units (170 cases) were distributed nationwide, including to Alabama, Arkansas, Arizona, Iowa, Illinois, Indiana, Louisiana, Massachusetts, North Carolina, Nebraska, New Mexico, South Carolina, Tennessee, Texas, Wisconsin, and West Virginia. Users should stop using the affected product and contact Stryker for instructions.
The recalled product
- 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 Classif
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Category
- Medical Device — Surgical Drapes
- Hazard
Distribution
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