Device product
InControl Insulin Syringes, Short Needle, 29 Gauge, 1CC
Z-0266-2023
Product summary
- Event
- Event 91083
- Status
- Completed
- Classification
- Class II
- Quantity
- 1,500 Boxes (150,000 syringes)
- Official record key
device-enforcement:Z-0266-2023
Official wording
Reason: Insulin syringe retail packages incorrectly labeled as "Short Needle".
Code information: UDI/Lot/Expiration: 00041220791484/ 170407/ 2022-03-31
Distribution pattern: Texas
Derived failure modes
-
Labeling or packaging
incorrectly labeled