FDAFDA · Food and drugs·Recall number Z-2644-2020
LoFric Origo, Tiemann, 16in, FR12 urinary catheters
Published July 29, 2020 · Recall initiated: June 17, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo" urethral catheters due to a potential defect which may be present in the catheters distal tip.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Wellspect HealthCare (Division of DENTSPLY IH AB)
- Distributor
- 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
- Lot
- Lot # 450422
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Sweden
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