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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1328-2014

5/10 Weck Vista Universal Balloon Open Access Port - Standard Length (70mm), Catalog No. 410944, 5/10 Weck Vista Universal Balloon Open Access Port - Long Length (100mm), Catalog No. 410944L; 5/10 Weck Vista Universal Balloon Open Access Port - Short Length (53mm), Catalog No. 410944S; 5/10/12 Weck Vista Universal Balloon Open Access Port - Standard Length (70mm), Catalog No. 412944; 5/10/12 Weck Vista Universal Balloon Open Access Port - Long Length (100 mm), Catalog No. 412944L. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.

Publicado el 9 de abril de 2014 · Inicio del retiro: 11 de marzo 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

Complaints of leakage of insufflation gas through the device.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Teleflex Medical
Distribuidor
Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, KY, MD, MA, MI, MN, MS, MO, NH, NJ, NY, NC, ND, OH, OR, PA, SC, TN, UT, VA, WA, WV, WI and the countries of Australia, Brazil, Canada, China, Israel, Korea, Malaysia, Singapore, and Vietnam.
Lote
Lots  Catalog No. 410944 - 01K1200601, 01K1200623, 01L1200355, 01L1200378, 01A1300203, 01D1300412, 01J1200241, 01K1200066, 01K1200622; Catalog No. 410944L - 01J1200219, 01K1200067, 01K1200600, 01L1200056, 01L1200354, 01A1300202, Catalog No. 410944S - 01L1200460, 01K1200619, 01L1200515, 01E1300137; Catalog No. 412944  01J1200241, 01K1200066, 01K1200622; Catalog No. 412944L - 01J1200231, 01K1200597, 01K1200618, 01K1200728, 01A1300178, 01D1300316, 01E1300310, 01E1300436
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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