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Recall Observatory FDA recall evidence

Device product

Petfine Auto Injector, REF 3310VET

Z-0264-2020

July 17, 2019

Class II

Product summary

Firm
Owen Mumford USA, Inc.
Event
Event 83465
Status
Ongoing
Classification
Class II
Quantity
140 units
Official record key
device-enforcement:Z-0264-2020

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: batches V14.V976 and V14.W107

Distribution pattern: FL, LA, SC, CA, NJ, TX, NC, CO, NH, KY, NY, MO, PA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    assembly error