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U.S. Department of Health and Human Services

Class 2 Device Recall LoFric Origo, Straight Tip, 16in, FR10 urinary catheters

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 Class 2 Device Recall LoFric Origo, Straight Tip, 16in, FR10 urinary catheterssee related information
Date Initiated by FirmJune 17, 2020
Create DateJuly 17, 2020
Recall Status1 Terminated 3 on April 09, 2021
Recall NumberZ-2643-2020
Recall Event ID 85905
510(K)NumberK122078 
Product Classification Catheter, straight - Product Code EZD
ProductLoFric Origo, Nelaton, 16in, FR10 urinary catheters
Code Information Lot # 447123 
FEI Number 3009632672
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 catheter s 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
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