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Recall Observatory FDA recall evidence

Device product

LoFric Origo, Tiemann, 16in, FR12 urinary catheters

Z-2644-2020

June 17, 2020

Class II

Product summary

Firm
Wellspect HealthCare (Division of DENTSPLY IH AB)
Event
Event 85905
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-2644-2020

Official wording

Reason: Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo" urethral catheters due to a potential defect which may be present in the catheters distal tip.

Code information: Lot # 450422

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo" urethral catheters due to a potential defect which may be present in the catheters distal tip.