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Terminated

LoFric Origo, Nelaton, 16in, FR10 urinary catheters

FDA Recall Z-2643-2020 · Posted None

Recalling FirmWellspect HealthCare (Division of DENTSPLY IH AB)
Recall StatusTerminated
Product CodeEZD
Date Initiated2020-06-17
Date Terminated2021-04-09

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.

Firm Action

Effected catheters must be not used and should be immediately returned. Wellspect issued an urgent medical device field notice dated June 19, 2020 to customers.

Root Cause

Equipment maintenance

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K122078LOFRIC PRIMO, LOFRIC HYDRO-KITAstra Tech, Inc. · 2012-10-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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