FDAFDA · Alimentos y medicamentos·N.º oficial Z-2610-2014
PROXIMATE Skin Stapler. PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35), PROXIMATE PX Fixed-Head Skin Stapler (Model PXR35), Bulk/Non-Sterile PROXIMATE RH Rotating-Head Skin Stapler (Model CK 117), and Bulk/Non-Sterile PROXIMATE PX Fixed-Head Skin Stapler (Model CK 158). Skin stapler for use in a single patient, which is designed to apply rectangular stainless steel staples for routine wound closure.
Publicado el 17 de septiembre de 2014 · Inicio del retiro: 12 de agosto de 2014
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
The device may have a non-conforming component that may cause the device to fire an unformed staple.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Ethicon Endo-Surgery Inc
- Distribuidor
- Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY; and countries of: Armenia, Belgium, Germany, Denmark, Finland, France, UK, Italy, Japan, South Korea, Netherlands, Norway, Russia, Sweden, Singapore, Taiwan, Tanzania, and South Africa.
- Lote
- PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35) Batch L4EG3F L4EK3Y L4EP22 L4ER1D L4ER9X L4EU87 PROXIMATE PX Fixed-Head Skin Stapler (Model PXR35) Batch L4EG2T L4EH20 L4EH85 L4EK50 L4EN58 L4EN94 L4EP2F L4EP6G L4ER1L L4EU0J L4EV07 Bulk/Non-Sterile PROXIMATE RH Rotating-Head Skin Stapler (Model CK 117) Batch L91J4U L91K38 L91K6N L91M8N L91N22 L91W33 L91X5V Bulk/Non-Sterile PROXIMATE PX Fixed-Head Skin Stapler (Model CK 158) Batch L90W40 L90X3C L90Y0U L90Y4V L90Z7C L9108Z L91151 L91223 L91970 L91A7N L91C5C L91E2Z L91E6P L91G46 L91J4L L91K3A L91M4U L91T81
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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