Device product
Perfectum Tuberculin Glass Syringe, Non sterile Catalog numbers 5202, 5205, 5212
Z-2364-2015
Product summary
- Firm
- Cadence Inc.
- Event
- Event 71674
- Status
- Terminated
- Classification
- Class II
- Quantity
- 766 units
- Official record key
device-enforcement:Z-2364-2015
Official wording
Reason: Graduation marks of the syringe are not centered with the numeric position marks on the syringe barrel.
Code information: Packged Lots: Catalog Number 5202: 79713-04, 80468-05, W003542/1, W006324/1, W006324/2, W006324/3, W006324/4, W006324/5; Catalog Number 5205: 79748-03; Catalog Number 5212: W008136/1, W008686/1, W011240/1, W010905/1, W012135/1, W014053/1, W015838/1, W011240
Distribution pattern: Nationwide Foreign Canada, Denmark. Italy
Derived failure modes
-
Unknown
Graduation marks of the syringe are not centered with the numeric position marks on the syringe barrel.