Device product
Autoject EI, REF AJ1310
Z-0263-2020
Product summary
- Event
- Event 83465
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1510 units
- Official record key
device-enforcement:Z-0263-2020
Official wording
Reason: There is a possible assembly error on Autoject EI, lot number V14. This lot was packed into two products: AJ 1310, lot number V14 and AN 3310VET (branded as Petfine Auto Injector), batches V14.V976 & V14.W107
Code information: Lot/Unit Number: V14
Distribution pattern: FL, LA, SC, CA, NJ, TX, NC, CO, NH, KY, NY, MO, PA
Derived failure modes
-
Manufacturing or process control
assembly error