Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Petfine Auto Injector

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Petfine Auto Injectorsee related information
Date Initiated by FirmJuly 17, 2019
Create DateNovember 01, 2019
Recall Status1 Open3, Classified
Recall NumberZ-0264-2020
Recall Event ID 83465
510(K)NumberK945660 
Product Classification Introducer, syringe needle - Product Code KZH
ProductPetfine Auto Injector, REF 3310VET
Code Information batches V14.V976 and V14.W107
Recalling Firm/
Manufacturer		 Owen Mumford USA, Inc.
1755 W Oak Commons Ct
Marietta GA 30062-2280
For Additional Information ContactTravis Shaw
770-977-2226 Ext. 12
Manufacturer Reason
for Recall		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
FDA Determined
Cause 2		Employee error
ActionThe 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 in Commerce140 units
DistributionFL, LA, SC, CA, NJ, TX, NC, CO, NH, KY, NY, MO, PA
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = KZH
-
-