FDA recall Z-1509-2018
Stryker Instruments Div. of Stryker Corporation · Class II · device
Product
T4 Zipper Toga, X-Large; Catalog number: 0400-850-000 Sterile personal protection garment
Reason for recall
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
Distribution
US Nationwide and Ireland, Japan, South Korea, UK
Key facts
- Status
- Terminated
- Initiation date
- 2018-02-23
- Report date
- 2018-05-02
- Termination date
- 2019-05-23
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Portage, MI, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1509-2018