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U.S. Department of Health and Human Services

Class 2 Device Recall Unifine Pentips 5mm x 31G pen needles

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  Class 2 Device Recall Unifine Pentips 5mm x 31G pen needles see related information
Date Initiated by Firm November 06, 2017
Create Date January 17, 2018
Recall Status1 Terminated 3 on February 12, 2021
Recall Number Z-0382-2018
Recall Event ID 78483
510(K)Number K152339  
Product Classification Needle, hypodermic, single lumen - Product Code FMI
Product Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles.

Product Usage:
Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors.
Code Information UPC #384701150012: Batch No. AN 1150, Lot No.1705711.T098; Batch No. 1150REC, Lot No. 1705722.T099; Batch No. AN 1150HEB, Lot No. 1705722.T100.
Recalling Firm/
Manufacturer		 Owen Mumford USA, Inc.
1755 W Oak Commons Ct
Marietta GA 30062-2280
For Additional Information Contact Travis Shaw
770-977-2226
Manufacturer Reason
for Recall		 Device may potentially be compromised by water in end user packaging. Exposure to liquid may compromise sterility. This may appear as discoloring or yellowing of the device's protective seal.
FDA Determined
Cause 2		 Environmental control
Action Owen Mumford sent an Urgent Medical Device Recall Notification letter dated November 6, 2017 via email. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to check inventory for affected product, contact the Customer Service Department to arrange return of affected product, complete and return the response form and to either provide a customer list for Owen and Mumford to notify their customers or confirmation that they will notify their customers if further distributed.
Quantity in Commerce 708 cartons (21,240 pen needles)
Distribution US 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, NX, UT, VA, VT, WA, WV
Total Product Life Cycle TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FMI and Original Applicant = OWEN MUMFORD LTD
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