Device product
T4 Zipper Toga, X-Large; Catalog number: 0400-850-000 Sterile personal protection garment
Z-1509-2018
Product summary
- Event
- Event 79779
- Status
- Terminated
- Classification
- Class II
- Quantity
- 34570 total products
- Official record key
device-enforcement:Z-1509-2018
Official wording
Reason: Separation of material layers may occur, causing a potential risk of exposure to contaminants.
Code information: Lot numbers: 17061835, 17061838, 17061857, 17071891, 17071904, 17071928, 17102898, 17102943, 17102957, 17102972, 17111362, 17113014, 17113022, 17113038, 17113080, 17113140, 17113205, 17113223
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.