FDAFDA · Alimentos y medicamentos·N.º oficial Z-0225-2020
Synchro2, 0.014 in x 200cm, SOFT Guidewire with Hydrophilic Coating, UPN Product No. M00326010 REF 2601, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
Publicado el 6 de noviembre de 2019 · Inicio del retiro: 8 de junio de 2018
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 product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Stryker Neurovascular
- Distribuidor
- Worldwide distributions- U.S. Nationwide including the states of AL, AZ, AR, CA, CO, CT, DC, DE, FL, GA, GU, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY. Countries of Austria, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Jordan, Lithuania, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, UAE, and UK.
- Lote
- UPN: M00326010 Lot Numbers/UDI:0000000558 /(01)04546540688729(17)201031(10)0000000558; 0000000560/ (01)04546540688729(17)201031(10)0000000560; 0000000671/ (01)04546540688729(17)201031(10)0000000671; 0000000672/ (01)04546540688729(17)201031(10)0000000672; 0000000980/ (01)04546540688729(17)201031(10)0000000980; 0000000987/ (01)04546540688729(17)201031(10)0000000987; 0000001013/ (01)04546540688729(17)201031(10)0000001013; 0000001014/ (01)04546540688729(17)201031(10)0000001014; 0000001275/ (01)04546540688729(17)201031(10)0000001275; 0000001274/ (01)04546540688729(17)201031(10)0000001274; 0000001276/ (01)04546540688729(17)201031(10)0000001276; 0000001287/ (01)04546540688729(17)201031(10)0000001287; 0000001285/ (01)04546540688729(17)201031(10)0000001285; 0000001492/ (01)04546540688729(17)201031(10)0000001492; 0000001286/ (01)04546540688729(17)201031(10)0000001286; 0000001493/ (01)04546540688729(17)201031(10)0000001493; 0000001909/ (01)04546540688729(17)201130(10)0000001909; 0000001910/ (01)04546540688729(17)201130(10)0000001910; 0000002053/ (01)04546540688729(17)201130(10)0000002053; 0000002054/ (01)04546540688729(17)201130(10)0000002054; 0000002425/ (01)04546540688729(17)201231(10)0000002425; 0000002639/ (01)04546540688729(17)201231(10)0000002639; 0000002638/ (01)04546540688729(17)201231(10)0000002638; B47912/ (01)04546540688729(17)200930(10)B47912; 0000002764/ (01)04546540688729(17)201231(10)0000002764; 0000002765/ (01)04546540688729(17)201231(10)0000002765; 0000003120/ (01)04546540688729(17)201231(10)0000003120; 0000003463/ (01)04546540688729(17)210131(10)0000003463; 0000003458/ (01)04546540688729(17)210131(10)0000003458; 0000003462/ (01)04546540688729(17)210131(10)0000003462; 0000003593/ (01)04546540688729(17)210109(10)0000003593; 0000003946/ (01)04546540688729(17)210131(10)0000003946; 0000003461/ (01)04546540688729(17)210131(10)0000003461; 0000003460/ (01)04546540688729(17)210131(10)0000003460; 0000003947/ (01)04546540688729(17)210131(10)0000003947; 0000003948/ (01)04546540688729(17)210131(10)0000003948; 0000003679/ (01)04546540688729(17)210111(10)0000003679; 0000004122/ (01)04546540688729(17)210131(10)0000004122; 0000004123/ (01)04546540688729(17)210131(10)0000004123; 0000004356/ (01)04546540688729(17)210131(10)0000004356; 0000004357/ (01)04546540688729(17)210131(10)0000004357; 0000004359/ (01)04546540688729(17)210131(10)0000004359; 0000004360/ (01)04546540688729(17)210131(10)0000004360; 0000004358/ (01)04546540688729(17)210131(10)0000004358; 0000004639/ (01)04546540688729(17)210228(10)0000004639; 0000004642/ (01)04546540688729(17)210228(10)0000004642; 0000004640/ (01)04546540688729(17)210228(10)0000004640; 0000004905/ (01)04546540688729(17)210228(10)0000004905; 0000004998/ (01)04546540688729(17)210214(10)0000004998; 0000005342/ (01)04546540688729(17)210228(10)0000005342; 0000005270/ (01)04546540688729(17)210222(10)0000005270; 0000005534/ (01)04546540688729(17)210331(10)0000005534; 0000005536/ (01)04546540688729(17)210331(10)0000005536; 0000005535/ (01)04546540688729(17)210331(10)0000005535; 0000005537/ (01)04546540688729(17)210331(10)0000005537; 0000005850/ (01)04546540688729(17)210331(10)0000005850; 0000005851/ (01)04546540688729(17)210331(10)0000005851; 0000006312/ (01)04546540688729(17)210331(10)0000006312; 0000006431/ (01)04546540688729(17)210321(10)0000006431; 0000006465/ (01)04546540688729(17)210322(10)0000006465; 0000006477/ (01)04546540688729(17)210331(10)0000006477; 0000006478/ (01)04546540688729(17)210331(10)0000006478; 0000006925/ (01)04546540688729(17)210402(10)0000006925; 0000006616/ (01)04546540688729(17)210331(10)0000006616; 0000006950/ (01)04546540688729(17)210404(10)0000006950; 0000006997/ (01)04546540688729(17)210430(10)0000006997; 0000007313/ (01)04546540688729(17)210430(10)0000007313; 0000007314/ (01)04546540688729(17)210430(10)0000007314; 0000007417/ (01)04546540688729(17)210430(10)0000007417; 0000007422/ (01)04546540688729(17)210430(
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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