Device product
T4 Pullover Toga, L/XL; Catalog Number: 0400-720-000 Sterile personal protection garment
Z-1501-2018
Product summary
- Event
- Event 79779
- Status
- Terminated
- Classification
- Class II
- Quantity
- 34570 total products
- Official record key
device-enforcement:Z-1501-2018
Official wording
Reason: Separation of material layers may occur, causing a potential risk of exposure to contaminants.
Code information: Lot numbers: 17113078, 17113132, 17113138
Distribution pattern: US Nationwide and Ireland, Japan, South Korea, UK
Derived failure modes
-
Unknown
Separation of material layers may occur, causing a potential risk of exposure to contaminants.