FDAFDA · Alimentos y medicamentos·N.º oficial Z-3219-2017
Percuvance Gripper Grasper Tool Tip The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok ligating clips to soft tissue during laparoscopic surgery.
Publicado el 4 de octubre de 2017 · Inicio del retiro: 19 de julio de 2017
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. For certain other recalled lots of the products, the jaws of the tool tips may close abruptly.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Teleflex Medical
- Distribuidor
- Worldwide Distribution - US including AL, AZ, CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV Internationally to United Arab Emirates, Vienna, Australia, Belgium, Switzerland, China, Germany, Czech Republic, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, Iran, Italy, Japan, South Korea, R¿publique du Liban, Netherlands, Norway, Qatar, Romania, Saudi Arabia, Republic of Singapore, Turkey, Taiwan, and South Africa
- Lote
- Lot #'s: 73A1600103, 73B1600340, 73C1600290, 73C1600451, 73E1600256, 73G1600559, 73G1600726, 73H1600147, 73H1600340, 73H1600900, 73J1600599, 73K1600501, 73L1600558, and 73M1500034.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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