Gown, Surgical
Stryker Instruments's record for this product code
Recent MDR events
372 adverse event reports on file
- STRYKER FLYTE HOOD, PEEL-AWAYJul 17, 2025MalfunctionMW5172880
- FLYTE SURGICOOL TOGA, 2XL, PULLOVERApr 21, 2025Malfunction3015967359-2025-00911
- FLYTE HOODApr 21, 2025Malfunction3015967359-2025-00912
- FLYTE TOGA, 2XL, ZIPPER, PEELAWAYApr 21, 2025Malfunction3015967359-2025-00924
- FLYTE HOODJan 22, 2025Malfunction3015967359-2025-00331
- FLYTE HOODOct 22, 2024Malfunction3015967359-2024-02214
- FLYTE HOODOct 22, 2024Malfunction3015967359-2024-02228
- FLYTE HOOD, PEELAWAYJul 24, 2024Malfunction3015967359-2024-01352
- FLYTE HOODJul 24, 2024Malfunction3015967359-2024-01478
- T7PLUS ZIPPER TOGA W ANTI-REFLECTIVE LENS XLJun 5, 2024Malfunction3015967359-2024-01120
Recalls
30 recall events for this product code
- TerminatedFeb 10, 2015
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.
View FDA record ↗ - TerminatedJun 6, 2013
Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr
View FDA record ↗ - TerminatedJun 6, 2013
Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr
View FDA record ↗ - TerminatedJun 6, 2013
Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr
View FDA record ↗ - TerminatedJun 6, 2013
Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr
View FDA record ↗ - TerminatedJun 6, 2013
Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr
View FDA record ↗ - TerminatedJun 6, 2013
Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr
View FDA record ↗ - TerminatedJun 6, 2013
Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr
View FDA record ↗ - TerminatedJun 6, 2013
Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr
View FDA record ↗ - TerminatedJun 6, 2013
Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr
View FDA record ↗
510(k) clearances
7 clearances for this product code
- K241272Oct 16, 2024
Stryker Steri-Shield 8 Surgical Hoods and Togas
- K073017Nov 30, 2007
STRYKER STRI-SHIELD FLYTE TOGAS
- K063005Mar 23, 2007
STRYKER T6 HOODS AND TOGAS
- K070078Feb 2, 2007
STRYKER T4 HYTREL TOGA
- K022162Aug 1, 2002
STRYKER T4 URETHANE HOOD; STRYKER T4 URETHANE ZIPPER TOGA; STRYKER T4 URETHANE PULLOVER TOGA
- K994053Dec 20, 1999
STRYKER T4 POWER PACK, STRYKER T4 EIGHT STATION BATTERY CHARGER, STRYKER T4 CHARGER MODULE
- K993148Oct 15, 1999
STRYKER T4 HOOD, STRYKER T4 ZIPPERED TOGA, STRYKER T4 PULLOVER TOGA