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  • Dispositivo 329
  • Fabricante 31827
  • Evento 350
  • Implante 8
Device Recall Clinical Innovations
  • Modelo / Serial
    Lots: 0314-F-566; 0814-F-100; 0814-F-108; 0814-V-068
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of : Canada, Finland, Estonia, Belgium, Ireland, Sweden, France, Switzerland, Spain, Netherlands, Middle East, Scotland, Germany and Wales.
  • Descripción del producto
    Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
  • Manufacturer
    Clinical Innovations, LLC
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Clinical Innovations
Device Recall CooperSurgcial
  • Modelo / Serial
    Lot numbers: 144351, 142789
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm || Part Number: MXKPEC02
  • Manufacturer
    CooperSurgical, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall CooperSurgcial
Device Recall Ameda
  • Modelo / Serial
    SKU 17161; Lot 5A22
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including CA, FL, GA, IA, IL, IN, LA, MA, MD, MO, MS, NC, NJ, NY, OK, PA, RI, SC, TN, TX, UT, VA, and WA.
  • Descripción del producto
    Ameda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouches with Tyvek header (9.5 x 13.63 x 3.75") within a secondary corrugated shipper (16 x 11.02 x 5.12" inner dimensions). || The device is indicated for assisted expression of milk using manual suction.
  • Manufacturer
    Ameda, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Ameda
Device Recall Ameda
  • Modelo / Serial
    SKU 17115; Lot 5B01
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including CA, FL, GA, IA, IL, IN, LA, MA, MD, MO, MS, NC, NJ, NY, OK, PA, RI, SC, TN, TX, UT, VA, and WA.
  • Descripción del producto
    Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115) - Primary packaging is 12 pouches with Tyvek header (10.75 x 16.375 x 3") within a secondary corrugated shipper (20.75 x 15.50 x 8.5" inner dimensions). || The device is intended to be connected to a powered breast pump or adapted for use with a manual breast pump to express and collect the mother's milk of a nursing woman for the purpose of feeding the collected milk to a baby.
  • Manufacturer
    Ameda, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Ameda
Device Recall Ally Uterine Positioning System (Ally UPS)
  • Modelo / Serial
    Serial Numbers: 020015;020021;020023; 020043;020051
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed in the states of CA, IL, NC, and NY.
  • Descripción del producto
    Ally Uterine Positioning System (Ally UPS) used in the mounting and positioning and holding of uterine manipulators || during gynecological laproscopic procedures || Model: Ally UPS
  • Manufacturer
    CooperSurgical, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Ally Uterine Positioning System (Ally UPS)
Device Recall CooperSurgical MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80
  • Modelo / Serial
    Lot 153309
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    AK, CA, DC, FL, IL, ME, MT, NE, NJ, NM, NY, OK, OR, P A, VA, W A, and WI Foreign: CANADA, ENGLAND, and POLAND
  • Descripción del producto
    MILEX OMNIFLEX DIAPHRAGM SIZE 80 || Model: MXWF80
  • Manufacturer
    CooperSurgical, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall CooperSurgical MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80
Device Recall CooperSurgical
  • Modelo / Serial
    LOT 156966
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution in the states of: CA, FL, GA, HI, IL, KY, MD, MN, NC, NY, OH, TX, VT, and W A.
  • Descripción del producto
    Milex Vaginal-Hymenal Silicone Dilators Set of 4 || P/N MX20 || Product Usage: || The CooperSurgical Milex Vaginal-Hymenal Silicone Dilators are used for progressive vaginal dilation therapy involving the treatment of vaginismus (muscular spasm of the vagina) and conditions that result in constriction of the vaginal and/or rectal orifice
  • Manufacturer
    CooperSurgical, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall CooperSurgical
Device Recall Insuffflation needle
  • Modelo / Serial
    OEM Catalog number C2201.
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed in DC and the states of CO, CA, FL, TX, and AR.
  • Descripción del producto
    Medical Device Exchange Insufflation Needle; || Pouch, Tyvek/Mylar, Sterile, Single Use Only; || OEM Catalog number C2201; || EXP (repackager), Medline (OEM) || Insufflator, laparoscopic
  • Manufacturer
    EXP Pharmaceutical Services Corp
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Insuffflation needle
Device Recall Obstetrical kit
  • Modelo / Serial
    Catalog number:900012  Lots: 141015742 exp. 4/30/15 150116712 exp. 3/31/16 150519091 exp. 5/31/16
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed Only in Puerto Rico.
  • Descripción del producto
    O.B. PK 4/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
  • Manufacturer
    Customed, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Obstetrical kit
Device Recall Obstetrical pack
  • Modelo / Serial
    Code: 9001030  Lots: 141015753 exp. 10/31/15 140915228 exp. 10/31/15
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed Only in Puerto Rico.
  • Descripción del producto
    OB PACK CS/4 || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
  • Manufacturer
    Customed, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Obstetrical pack
Device Recall PERI GYN PACK
  • Modelo / Serial
    Code:9001061  Lots: 141015757 exp. 10/31/15 141216313 exp. 12/31/15 150116727 exp. 1/31/16 150116973 exp. 1/31/16 150116980 exp. 1/31/16 150418280 exp. 4/30/16 150518620 exp. 5/31/16 150519110 exp. 5/31/16
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed Only in Puerto Rico.
  • Descripción del producto
    PERI GYN PACK CS/6 || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
  • Manufacturer
    Customed, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall PERI GYN PACK
Device Recall PERY GYN PACK
  • Modelo / Serial
    Code:9001091  Lots: 141015789 exp. 5/31/19 141115972 exp. 12/31/15 150116985 exp. 1/31/16 150217441 exp. 2/28/16 150217442 exp. 2/28/16 150418281 exp. 4/30/16 150518223 exp. 5/31/16 150519018 exp. 5/31/16
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed Only in Puerto Rico.
  • Descripción del producto
    PERY GYN PACK CUSTOMED 10/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
  • Manufacturer
    Customed, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall PERY GYN PACK
Device Recall LAPAROSC. OB GYN PK
  • Modelo / Serial
    Code:9001192 Lots: 141015514 exp. 10/31/15 141015514 exp. 10/31/15 150116565 exp. 1/31/16 150217443 exp. 3/31/16 150317586 exp. 3/31/16 150217357 exp. 3/31/16 150518805 exp. 6/30/16
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed Only in Puerto Rico.
  • Descripción del producto
    LAPAROSC. OB GYN PK 5/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
  • Manufacturer
    Customed, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall LAPAROSC. OB GYN PK
Device Recall PREMIUM CESAREAN PACK
  • Modelo / Serial
    Code:9001294 Lots: 141015769 exp. 11/30/15 141115974 exp. 12/31/15 150116729 exp. 1/31/16 150217261 exp. 1/31/16 150318132 exp. 3/31/16 150418450 exp. 4/30/16
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed Only in Puerto Rico.
  • Descripción del producto
    PREMIUM CESAREAN PACK CUSTOMED 5/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
  • Manufacturer
    Customed, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall PREMIUM CESAREAN PACK
Device Recall PREMIUM O.B. PACK
  • Modelo / Serial
    Code:9001297  Lots: 141015609 exp. 10/31/15 141115976 exp. 11/30/15 150116757 exp. 2/28/16 150116758 exp. 2/28/16 150116756 exp. 2/28/16 150619380 exp. 6/30/16
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed Only in Puerto Rico.
  • Descripción del producto
    PREMIUM O.B. PACK CUSTOMED 5/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
  • Manufacturer
    Customed, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall PREMIUM O.B. PACK
Device Recall CESAREAN PACK
  • Modelo / Serial
    Code:9001689 Lots: 140915235 exp. 10/31/16 141015761 exp. 10/31/15 141216414 exp. 1/31/16 150217448 exp. 3/31/16
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed Only in Puerto Rico.
  • Descripción del producto
    CESAREAN PACK 3/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
  • Manufacturer
    Customed, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall CESAREAN PACK
Device Recall LABOR & DELIVERY
  • Modelo / Serial
    Code:900168 Lots: 141015759 exp. 1/31/18 141216295 exp. 12/31/15 150116561 exp. 1/31/16 150217277 exp. 2/28/16 150317631 exp. 3/31/16 150418312 exp. 5/31/16 150418313 exp. 5/31/16 150518656 exp. 5/31/16 150619177 exp. 6/30/16
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed Only in Puerto Rico.
  • Descripción del producto
    LABOR & DELIVERY 4/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
  • Manufacturer
    Customed, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall LABOR & DELIVERY
Device Recall PERI GYN PACK
  • Modelo / Serial
    Code:9001716 Lots: 141015510 exp. 10/31/15 141216415 exp. 12/31/15 150116976 exp. 1/31/16
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed Only in Puerto Rico.
  • Descripción del producto
    PERI GYN PACK 10/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
  • Manufacturer
    Customed, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall PERI GYN PACK
Device Recall O.B. PACK
  • Modelo / Serial
    Code:9001717 Lots: 141015731 exp. 3/31/19 141015731 exp. 3/31/19 141216416 exp. 12/31/15 150217279 exp. 3/31/16 150317691 exp. 5/31/16 150518659 exp. 5/31/16
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed Only in Puerto Rico.
  • Descripción del producto
    O.B. PACK 4/CS REV. || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
  • Manufacturer
    Customed, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall O.B. PACK
Device Recall CESAREAN PACK
  • Modelo / Serial
    Code:9001719 Lots: 140915239 exp. 10/31/15 141015732 exp. 11/30/15 150116697 exp. 1/31/16 150418265 exp. 4/30/16
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed Only in Puerto Rico.
  • Descripción del producto
    CESAREAN PACK 4/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
  • Manufacturer
    Customed, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall CESAREAN PACK
Device Recall O.B. PACK
  • Modelo / Serial
    Code:900254 Lots: 140915319 exp. 3/31/17 141015737 exp. 10/31/15 141216441 exp. 1/31/16
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed Only in Puerto Rico.
  • Descripción del producto
    O.B. PACK 5/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
  • Manufacturer
    Customed, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall O.B. PACK
Device Recall OBSTETRICAL SURGICAL PACK
  • Modelo / Serial
    Code:9002940 Lots: 140915333 exp. 2/28/19 141116022 exp. 12/31/15 141116022 exp. 12/31/15 150418387 exp. 4/30/16 150418388 exp. 4/30/16 150418497 exp. 4/30/16 150418496 exp. 4/30/16 150518909 exp. 5/31/16 150518910 exp. 5/31/16 150619184 exp. 6/30/16 150619183 exp. 6/30/16 150619183 exp. 6/30/16
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed Only in Puerto Rico.
  • Descripción del producto
    OBSTETRICAL SURGICAL PACK 4/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
  • Manufacturer
    Customed, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall OBSTETRICAL SURGICAL PACK
Device Recall CESAREAN PACK
  • Modelo / Serial
    Code:900403 Lots: 141015707 exp. 10/31/15 141216329 exp. 12/31/15 150116529 exp. 1/31/16 150116530 exp. 1/31/16 150116531 exp. 1/31/16 150116532 exp. 1/31/16 150317799 exp. 3/3/16 150317800 exp. 3/31/16 150317801 exp. 3/31/16 150317802 exp. 4/30/16 150418395 exp. 4/30/16 150418394 exp. 4/30/16 150418396 exp. 4/30/16 150518580 exp. 5/31/16 150518581 exp. 5/31/16
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed Only in Puerto Rico.
  • Descripción del producto
    CESAREAN PACK 3/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
  • Manufacturer
    Customed, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall CESAREAN PACK
Device Recall CESAREAN PACK
  • Modelo / Serial
    Code:900410 Lots: 141015763 exp. 10/31/15 140814986 exp. 10/31/15 141216332 exp. 12/31/15 141216332 exp. 12/31/15 150116562 exp. 1/31/16 150317651 exp. 3/31/16 150317975 exp. 3/31/16 150317978 exp. 3/31/16 150317976 exp. 4/30/16 150317977 exp. 4/30/15 150518814 exp. 5/31/16
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed Only in Puerto Rico.
  • Descripción del producto
    CESAREAN PACK 2/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
  • Manufacturer
    Customed, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall CESAREAN PACK
Device Recall LABOR & DELIVERY
  • Modelo / Serial
    Code:900419 Lots: 140613836 exp. 1/31/16 140814953 exp. 10/31/15 150116537 exp. 1/31/16 150116535 exp. 1/31/16 141216339 exp. 12/31/15 141216339 exp. 12/31/15 150418410 exp. 4/30/16 150418411 exp. 4/30/16 150518802 exp. 5/31/16 150518802 exp. 5/31/16
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed Only in Puerto Rico.
  • Descripción del producto
    LABOR & DELIVERY 4/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
  • Manufacturer
    Customed, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall LABOR & DELIVERY
  • 1
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Aviso

Los dispositivos médicos ayudan con el diagnóstico, la prevención y el tratamiento de muchas lesiones y enfermedades. A través de la International Medical Devices Database no estamos sugiriendo que compañías u otras entidades mencionadas en la base de datos hayan sido parte de una conducta ilegal o hayan actuado de manera impropia. Un mismo dispositivo médico puede tener distintos nombres en diferentes países. Esta base de datos no busca proporcionar asesoría médica. Los pacientes deben consultar con sus médicos para determinar si la data contiene información relevante y si la misma tiene implicaciones médicas para ellos.

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