Recall Z-1077-2015— Stryker Instruments Div. of Stryker Corporation
Class III · Terminated
Class III FDA medical device recall by Stryker Instruments Div. of Stryker Corporation, initiated 2014-12-22, terminated 2015-05-05. It names one FDA 510(k) clearance: K073017. 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).. 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..
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2014-12-22
- Terminated
- 2015-05-05
- Firm location
- Portage, MI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.