FDA-Device2020-07-29Class II
LoFric Origo, Tiemann, 16in, FR14 urinary catheters
Wellspect HealthCare (Division of DENTSPLY IH AB)
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.
Sold states
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
Affected count
N/A
Manufactured in
Aminogatan 1, N/A, Molndal, N/A, Sweden
Products
LoFric Origo, Tiemann, 16in, FR14 urinary catheters
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2645-2020Don't want to check this manually?
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