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 LoFric Origo, Straight Tip, 16in, FR14 urinary catheters

  • 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 LoFric Origo, Straight Tip, 16in, FR14 urinary catheterssee related information
Date Initiated by FirmJune 17, 2020
Create DateJuly 17, 2020
Recall Status1 Terminated 3 on April 09, 2021
Recall NumberZ-2645-2020
Recall Event ID 85905
510(K)NumberK122078 
Product Classification Catheter, straight - Product Code EZD
ProductLoFric Origo, Tiemann, 16in, FR14 urinary catheters
Code Information Lot #s: 447121, 447260, 449679, 450503 
Recalling Firm/
Manufacturer		 Wellspect HealthCare (Division of DENTSPLY IH AB)
Aminogatan 1
Molndal Sweden
For Additional Information ContactOlivia Uddenberg
877-4563742
Manufacturer Reason
for Recall		Wellspect Healthcare is voluntarily recalling certain LoFric Origo" urethral catheters due to a potential defect which may be present in the catheters distal tip.
FDA Determined
Cause 2		Equipment maintenance
ActionEffected catheters must be not used and should be immediately returned. Wellspect issued an urgent medical device field notice dated June 19, 2020 to customers.
DistributionAL, AZ, CA, CT, FL, GA, IL, IN, KY, MA, MD, MI, MO, NC, NH, NJ, OH, PA, RI, SC, TX, VA and Australia, Brazil, Canada, European Union, China, South Korea, Kuwait, New Zeeland, Singapore, United Kingdom
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = EZD
-
-