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 Unifine Pentips Plus

  • 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 Unifine Pentips Plussee related information
Date Initiated by FirmMay 26, 2021
Create DateJuly 15, 2021
Recall Status1 Open3, Classified
Recall NumberZ-2078-2021
Recall Event ID 88013
510(K)NumberK152339 
Product Classification Needle, hypodermic, single lumen - Product Code FMI
ProductUnifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover.
Code Information Lot numbers: 20V4001.Z3999, Lot 20V4001.Z4019 and 20V4001.Z411
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		Mixed Up. Two (2) cases of Unifine Pentips Plus 4mm pen needles have been mixed into a packed configuration of Unifine Pentips Plus 8mm pen needles.
FDA Determined
Cause 2		Package design/selection
ActionThe firm sent an e-mail on 05/06/2019 to all the distributors. The distributors were directed to quarantine all affected product and contact the company for return. Distributors were also directed to cease distribution and contact their customers (Pharmacies) with recall notification with instructions to contact Owen Mumford with product return, if any on hand..
Quantity in Commerce2,593 cartons of 100 ea.
DistributionUS Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, HI, IA, IL, MA, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OK, PA, TN, TX, UT, VA, VT, WA, and WV.
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 = FMI
-
-