Z-1077-2015 Class III Terminated
FDA device recall Z-1077-2015 was initiated by Stryker Instruments Div. Of Stryker Corporation on Dec 22, 2014 and is designated Class III. Reason for recall: 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… The recall status is terminated (terminated May 5, 2015). Affected quantity: 1530 units (170 cases).
Recall details
- Product Type
- Devices
- Report Date
- Feb 18, 2015
- Initiation Date
- Dec 22, 2014
- Termination Date
- May 5, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1530 units (170 cases)
Product description
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).
Reason for recall
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.
Distribution pattern
Nationwide Distribution including AL, AR, AZ, IA, IL, IN, LA, MA, NC, NE, NM, SC, TN, TX, WI, and WV.
Code information
Part/Catalog number: 0408-830-100 Lot number: 11121171 Expiration date (as printed): 2412-12-01
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1077-2015
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026