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Wellspect HealthCare (Division of DENTSPLY IH AB) recalls LoFric Origo, Tiemann, 16in, FR14 urinary catheters
Recalled July 29, 2020 · FDA recall Z-2645-2020 · 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. · FDA Class II
Units
N/A
Sold at
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
Description
Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo" urethral catheters due to a potential defect which may be present in the catheters distal tip.
Product
LoFric Origo, Tiemann, 16in, FR14 urinary catheters
Manufacturer(s)
Wellspect HealthCare (Division of DENTSPLY IH AB)
Made in
Sweden
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →