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Class 2 Device Recall LoFric Origo, Straight Tip, 16in, FR10 urinary catheters |
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| Date Initiated by Firm |
June 17, 2020 |
| Create Date |
July 17, 2020 |
| Recall Status1 |
Terminated 3 on April 09, 2021 |
| Recall Number |
Z-2643-2020 |
| Recall Event ID |
85905 |
| 510(K)Number |
K122078
|
| Product Classification |
Catheter, straight - Product Code EZD
|
| Product |
LoFric Origo, Nelaton, 16in, FR10 urinary catheters |
| Code Information |
Lot # 447123 |
Recalling Firm/
Manufacturer |
Wellspect HealthCare (Division of DENTSPLY IH AB)
Aminogatan 1
Molndal Sweden
|
| For Additional Information Contact |
Olivia Uddenberg
877-4563742
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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 |
| Action |
Effected catheters must be not used and should be immediately returned. Wellspect issued an urgent medical device field notice dated June 19, 2020 to customers. |
| Distribution |
AL, 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 Cycle |
TPLC Device Report
|
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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.
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| 510(K) Database |
510(K)s with Product Code = EZD and Original Applicant = ASTRA TECH, INC.
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