FDAFDA · Alimentos y medicamentos·N.º oficial Z-2258-2016
AUTOCOMP6 XP High Speed Compounder REF 58810
Publicado el 3 de agosto de 2016 · Inicio del retiro: 23 de junio de 2016
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
An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- The Metrix Company
- Distribuidor
- Product distributed to medical facilities in the following US states: AL, AZ, CA, CO, CT, FL, IA, IL, KS, LA, MA, MD, MN, NC, OH, PA, PR, TN, TX, UT, and WA. Product was also distributed internationally to the following countries: Australia, Canada, Dominican Republic, Malaysia, Turkey, and United Kingdom
- Lote
- 0001, 0002, 0003, 0004, 0005, 0006, 0007, 0008, 0009, 0010, 0011, 0012, 0013, 0014, 0015, 0016, 0017, 0018, 0019, 0020, 0021, 0022, 0023, 0024, 0025, 0026, 0027, 0028, 0029, 0030, 0031, 0032, 0033, 0034, 0035, 0036, 0037, 0038, 0039, 0040, 0041, 0042, 0043, 0044, 0045, 0046, 0047, 0048, 0049, 0050, 0051, 0052, 0053, 0054, 0055, 0056, 0057, 0058, 0059, 0060, 0061, 0062, 0063, 0064, 0065, 0066, 0067, 0068, 0069, 0070, 0071, 0072, 0073, 0074, 0075, 0076, 0077, 0078, 0079, 0080, 0081, 0082, 0083, 0084, 0085, 0086, 0087, 0088, 0089, 0090, 0091, 0092, 0093, 0094, 0095, 0096, 0097, 0098, and 0099
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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