Events

Retiro De Equipo (Recall) de Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC)

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Arrow International Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    68987
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0066-2015
  • Fecha de inicio del evento
    2014-08-06
  • Fecha de publicación del evento
    2014-10-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-10-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129204
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Catheter, percutaneous - Product Code DQY
  • Causa
    The component supplier recalled their 0.9% sodium chloride injection usp bd posiflush sf saline flush syringe 10ml because some unit packages may exhibit open seals which impact package integrity and potentially product sterility.
  • Acción
    Arrow International sent an Urgent Medical Device Recall Notification letter, dated August 6, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and quarantine any affected product. Customers were instructed to remove the BD pre-filled saline syringe from the exterior of the packaging. To return the BD syringes, customers were instructed to complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service. A customer service representative will contact the customer with a Return Good Authorization (RGA) Number and will provide instructions for the return of producet to Arrow International. All customers were asked to complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507. Attn: Customer Service. Customers with questions were instructed to contact their local sales representative or Customer Service at 1-866-246-6990.

Device

Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC)
  • Modelo / Serial
    Product Numbers: ASK-04001-VCUH, ASK-04510-MM3, ASK-05001-TSC, ASK-05052-QV, ASK-05052-SFL, ASK-05502-UWMC, ASK-05541-MS2, ASK-09804-SPH, ASK-09810-PCMH1, ASK-09903-ECL, ASK-09903-PCMH1, ASK-11142-MGH3, ASK-12703-MGH2, ASK-12703-SPH, ASK-15703-MH, ASK-15854-FAM ASK-17702-PJHH1, ASK-21142-HF2, ASK-21242-PCMH1, ASK-21242-SFM1,  ASK-21242-UVA3, ASK-29803-HF3, ASK-29803-MM, ASK-29803-MS, ASK-29903-UK, ASK-29903-UK, ASK-34041-PTG, ASK-34052-PTG, ASK-35052-PTG, ASK-42703-AMC, ASK-42703-OHU1, ASK-42703-PCCH1, ASK-42703-PCSJ, ASK-42703-PPMC, ASK-42703-PSBM, ASK-42703-PSCH, ASK-42703-PSFM, ASK-42703-PTRH, ASK-42703-SJMT, ASK-42703-UHC, ASK-42802-ECL1, ASK-42802-PMCG, ASK-42802-PUCS, ASK-42854-CMC2, ASK-45703-MM2, ASK-45703-NYU1, ASK-45703-PCCH1, ASK-45703-PCHS1, ASK-45703-PCSJ, ASK-45703-PDCH, ASK-45703-PGBM1, ASK-45703-PHCH, ASK-45703-PHF, ASK-45703-PHF1, ASK-45703-PHPA2, ASK-45703-PIA, ASK-45703-PLGH1, ASK-45703-PMHG, ASK-45703-PSA, ASK-45703-PTMC, ASK-45703-PUAB, ASK-45703-PUC ASK-45703-PUHC, ASK-45703-PUR, ASK-45703-PVCU, ASK-45703-UHC, ASK-45703-UKM, ASK-45802-PCMH1, ASK-45854-NG, ASK-45854-PCHS1, ASK-45854-PECL, CDC-02041-MK1A, CDC-05041-HPK1A, CDC-05052-HPK1A,  CDC-21242-X1A, CDC-24703-X1A, CDC-25123-X1A, CDC-25402-X1A, CDC-25502-X1A, CDC-25553-X1A, CDC-26553-X1A, CDC-29803-X1A, CDC-29903-X1A CDC-34052-HPK1A, CDC-35041-VPS, CDC-35052-HPK1A, CDC-35052-VPS,  CDC-35063-VPS, CDC-35563-VPS, CDC-42703-XP1A, CDC-42802-XP1A, CDC-42802-XP1A, CDC-44041-HPK1A, CDC-44052-HPK1A, CDC-45041-HPK1A, CDC-45041-VPS, CDC-45541-HPK1A, CDC-45541-VPS, CDC-45552-HPK1A, CDC-45703-XP1A, CDC-45703-XPB1A, CDC-45802-XP1A, CDC-45854-XP1A,  CDC-46702-XP1A, with lot numbers: 23F13H1030, 23F13H0046,RF3053077, 23F13J0406, 23F13H0230, 23F13J0435, 23F13J0440, 23F13H1031, 23F13J0181, 23F13G0409, 23F13H0060, 23F13H0231, RF3053088, 23F13H0232, 23F13H0062,  23F13H0233, RF3053092, RF3053096, 23F13J0072, 23F13H0520, 23F13H1032, 23F13H0064, 23F13J0446, 23F13H0804, 23F13J0187, 23F13H0069, 23F13J0193, 23F13H1033, 23F13G0724, 23F13H0898, RF3053035, 23F13J0202, 23F13H0297, RF3053111, 23F13H0521, 23F13G0402, 23F13G0404, 23F13H1034, 23F13G0495, 23F13J0399, 23F13H0072, 23F13H0808, 23F13H0810, 23F13H0313, RF3053655, 23F13J0208, 23F13H0315, 23F13H0768, 23F13J0254, RF3052973, 23F13J0204, 23F13J0037, 23F13J0352, 23F13J0207, 23F13H0687, 23F13H0512, 23F13J0349, 23F13J0452, RF3040503, 23F13G0472, RF3052873, 23F13J0400, 23F13J0401, 23F13H0816, 23F13H0817, 23F13H0818, 23F13J0241, 23F13H0451, 23F13H0861, 23F13H0858, 23F13H0819, 23F13G0830, 23F13H0519, 23F13H0821, 23F13J0351, 23F13G0473, 23F13J0217, 23F13J0073, RF3065022, 23F13H0045, 23F13H0916, 23F13H0796, 23F13J0403, 23F13J0542, 23F13H0127, 23F13J0454, 23F13J0057, 23F13J0291, 23F13J0080, 23F13J0076, 23F13H0994, 23F13H0013, 23F13H0993,  23F13H0022, RF3064650, 23F13H0919, 23F13J0160, 23F13H1018, 23F13J0162, 23F13J0166, 23F13H0911, RF3052890, 23F13J0167, RF3052884, RF3052536, RF3041482, 23F13J0178, RF3054066, 23F13J0135, 23F13J0014, 23F13H0349, 23F13H0351, 23F13H0266, 23F13H0036, 23F13H0265, 23F13H0707, 23F13H0709, 23F13H0941, 23F13J0319, 23F13J0133, 23F13J0390, 23F13J0137, 23F13G0578, 23F13J0331, 23F13H0750, 23F13H0267, 23F13H0752, 23F13H0753, 23F13J0304, 23F13J0298, 23F13J0301, 23F13H0751, 23F13J0303, 23F13G0217, 23F13H0268, 23F13H0269, 23F13H0270, RF3052159, RF3054123, RF3054125, 23F13H0759, 23F13J0249, 23F13H0668, 23F13H0664, 23F13H0706.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe.
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc
  • Dirección del fabricante
    Arrow International Inc, 2400 Bernville Rd, Reading PA 19605-9607
  • Empresa matriz del fabricante (2017)
    Teleflex Incorporated
  • Source
    USFDA