FDA recall Z-2643-2020

Product

LoFric Origo, Nelaton, 16in, FR10 urinary catheters

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.

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

Key facts

Status

Terminated

Initiation date

2020-06-17

Report date

2020-07-29

Termination date

2021-04-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Molndal, N/A, Sweden

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2643-2020