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FDA Medical Device Recalls (openFDA)

Owen Mumford USA, Inc.: Petfine Auto Injector, REF 3310VET

Recall number
Z-0264-2020
Recalling firm
Owen Mumford USA, Inc.
Product
Petfine Auto Injector, REF 3310VET
Status
Open, Classified
Initiated
2019-07-17
Posted
not on file
Terminated
not on file
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
Root cause
Employee error
Action
The firm initiated the recall by letter on 07/17/2019. The consignee was directed to quarantine all affected product and contact the company for return. Distributors were also directed to cease distribution and contact their customers.
Quantity
140 units
Distribution
FL, LA, SC, CA, NJ, TX, NC, CO, NH, KY, NY, MO, PA
Lot, serial or model codes
batches V14.V976 and V14.W107
510(k) numbers
["K945660"]
PMA numbers
not on file
Product code
KZH
Firm FEI
1000219614
Firm city
Marietta
Firm state
GA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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