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Recall Observatory FDA recall evidence

Device product

WECK Visistat 35R Disposable Skin Stapler, Ref 528135, Rx Only, Sterile EO, Visistat is indicated for the external skin closure of lacerations on the outer layer of the dermis for a wide range of general, thoracic, obstetric, gynecological, orthopedic, cardiovascular, urological, and plastic surgical procedures

Z-2108-2017

March 24, 2017

Class II

Product summary

Firm
Teleflex Medical
Event
Event 77102
Status
Completed
Classification
Class II
Quantity
3594 eaches
Official record key
device-enforcement:Z-2108-2017

Official wording

Reason: Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visistat Regular device.

Code information: 73H1600207

Distribution pattern: Worldwide Distribution - US including CA, FL, GA, IL, IN, KS, KY, ME, MD, MA, MI, NJ, NY, NC, OH, OR, RI, TX, UT, VA, and Internationally to Australia, Belgium and France

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visistat Regular device.