Device product
Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580
Z-0027-2020
Product summary
- Event
- Event 83738
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24 kits
- Official record key
device-enforcement:Z-0027-2020
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-10167, Lot # K12T-10167, Use By: 2018-11-05
Distribution pattern: U.S.: VA, IL
Derived failure modes
-
Labeling or packaging
Labeling error