Device product
Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409
Z-0026-2020
Product summary
- Event
- Event 83738
- Status
- Terminated
- Classification
- Class II
- Quantity
- 88 Kits
- Official record key
device-enforcement:Z-0026-2020
Official wording
Reason: Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling information (i.e. indicated Latex Free)
Code information: Catalog #K12T-03688H - Lot #T1401193 and #T1419935
Distribution pattern: U.S.: VA, IL
Derived failure modes
-
Labeling or packaging
Labeling error