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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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