Device product
T5 Zipper Toga with Peel-Away Face Shield, (L/XL); Catalog number: 0400-820-100 Sterile personal protection garment
Z-1507-2018
Product summary
- Event
- Event 79779
- Status
- Terminated
- Classification
- Class II
- Quantity
- 34570 total products
- Official record key
device-enforcement:Z-1507-2018
Official wording
Reason: Separation of material layers may occur, causing a potential risk of exposure to contaminants.
Code information: Lot numbers: 17061816, 17061836, 17061839, 17061853, 17071921, 17072017, 17102944, 17102948, 17113081, 17113141, 17113194
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.