Device product
T4 Pullover Toga, X-Large; Catalog Number: 0400-770-000 Sterile personal protection garment
Z-1504-2018
Product summary
- Event
- Event 79779
- Status
- Terminated
- Classification
- Class II
- Quantity
- 34570 total products
- Official record key
device-enforcement:Z-1504-2018
Official wording
Reason: Separation of material layers may occur, causing a potential risk of exposure to contaminants.
Code information: Lot numbers: 17061775, 17061781, 17061784, 17061793, 17102891, 17102916, 17102925, 17102995, 17113013, 17113083, 17113190
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.