Devices

Device Recall Customed

  • Modelo / Serial
    Product code 900-796, 14 lots: 113047032 113057507 113067965 113078346 113088892 113109873 131110279 131210842 140111251 140211700 140311949 140312388 140513145 140513340
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
  • Descripción del producto
    FEMORAL ANGIOGRAPHY PACK - || (1) TABLE COVER REINFORCED 50" X 90" UF || (1) GOWN LARGE SMS IMPERVIOUS REINFORCED LIF || (1) TOWEL ABSORBENT 15" X 20" UF || (1) DRAPE ANGlO 75" X 145" || (4) TOWELS CLOTH HUCK (BLUE) UF || (3) SYRINGE 1 Occ WITHOUT NEEDLE LUER LOCK UF || (1) IV ADM SET 15ML 1 06" LONG LIF || (20) GAUZE SPONGE 4" X 4" 12PL Y LIF || (1) NEEDLE HYPODERMIC 18G X 1Y:. ST. UF || (1) NEEDLE HYPODERMIC 21G X 1Y:. ST. LIF || (2) MEDICINE CUP 2oz. CLEAR LIF || (1) SCALPEL WEIGHTED SAFETY #11 || (2) CHLORASCRUB SWABSTICK 5.1 ML LIF || (1) GOWN SURG REINFORCED LARGE TOWEL/WRAP LIF || (1) SPECIMEN CONTAINER 4oz. W/LID & LABEL LIF || (1) NEEDLE HYPODERMIC 25G X 5/8 ST. LIF || (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF || (1) FORCEP ADS ON TISS. WITH TIP LIF || (1) UTILITY BOWL 32oz LIF || (1) UTILITY BOWL 16oz L/F || (1) FORCEP KELLY STRAIGHT 5.5" LIF || (1) MOSQUITO HALSTED CVD 5" LIF || (1) TRAY ORGANIZER FULL DEEP LIF || (1) SCISSOR MAYO 6.75 STRAIGHT LIF || (1) HOLDER NEEDLE WEBSTER 4.75 LIF || (1) GUIDEWIRE .035" X 150cm UF || (1) TIME OUT BEACON NON WOVEN ST. UF || (1) MAYO TRAY SMALL LIF || (2) TOWEL CLAMP UF || (2) BAG BAND RUBBAND & TAPE LIF || (1) Pr. GLOVE SURG. #7Y:. DERMA PRENE P/F LIF || (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF || LABEL SAMPLE || (1) NEEDLE & BLADE COUNTER 60C FOAM STRIP/MAG STRIP LIF || (1) NEEDLE 18G X 2 o/.i AMC/4 || (1) SKIN MARKER INK WITH/8 LABEL || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
  • Manufacturer
    Customed, Inc
  • 1 Event

Fabricante

Customed, Inc
  • Dirección del fabricante
    Customed, Inc, Calle Igualdad Final #7, Fajardo PR 00738
  • Empresa matriz del fabricante (2017)
    Customed Inc
  • Source
    USFDA

331 dispositivos con un nombre similar

Más información acerca de la data acá

Device Recall Customed
  • Modelo / Serial
    LOTS: SL15197 (150719633) 31-JUL-16 SL15201-01 (150719633)31-JUL-16 SL15201-02 (150719632)31-JUL-16 SL15203 (150719632) 31-JUL-16 SL15240 (150720068) 31-AUG-16 SL15240 (150820069) 31-AUG-16 SL15243 (150820069) 31-AUG-16
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed only in Puerto Rico.
  • Descripción del producto
    Catalog Number: 9001296 || PREMIUM LAPAROTOMY PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
  • Manufacturer
    Customed, Inc
Device Recall Customed
  • Modelo / Serial
    LOTS: SL15210 (150719663) 31-JUL-16 SL15244 (150820222) 31-AUG-16
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed only in Puerto Rico.
  • Descripción del producto
    Catalog Number: 900169 || UNIVERSAL SURGICAL PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
  • Manufacturer
    Customed, Inc
Device Recall Customed
  • Modelo / Serial
    LOT: SL15209 (150719960) 31-JUL-16
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed only in Puerto Rico.
  • Descripción del producto
    Catalog Number: 9001738 || UROLOGY SURGICAL PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
  • Manufacturer
    Customed, Inc
Device Recall Customed
  • Modelo / Serial
    LOTS: SV15168 (141015851) 31-OCT-15 SL15187 (150619088) 30-JUN-16 SL15187 (150719604) 31-JUL-16 SL15191-01 (150719604) 31-JUL-16 SL15261 (150920134) 30-SEP-16 SL15264 (150920725) 30-SEP-16 SL15264 (150920134) 30-SEP-16
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distributed only in Puerto Rico.
  • Descripción del producto
    Catalog Number: 900010 SUTURE REMOVAL KIT || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
  • Manufacturer
    Customed, Inc
Device Recall Customed
  • Modelo / Serial
    Catalog Number: 900012 LOTS: SL15202 (150719606) 31-JUL-16 SL15210 (150720034) 31-JUL-16 SL15219 (150720056) 31-JUL-16
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed only in Puerto Rico.
  • Descripción del producto
    Catalog Number: 900012 OB SURGICAL PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
  • Manufacturer
    Customed, Inc
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