Wellspect HealthCare (Division of DENTSPLY IH AB) recalls LoFric Origo, Nelaton, 16in, FR10 urinary catheters

Recall date

June 17, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2643-2020

FDA classification

Class II

Brand / firm

Wellspect HealthCare (Division of DENTSPLY IH AB)

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

LoFric Origo, Nelaton, 16in, FR10 urinary catheters