Device Recall Customed

  • Modelo / Serial
    Product code 900-2415 ,1 lots 140412654
  • Clasificación del producto
  • 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
    TOTAL HYCTERECTOMY || (I) CANNULA 5MM XCEL SLEEVES LIF ( I ) TROCAR XCEL BLADELESS II MM || (I) TROCAR 5MM BLADELESS W/STAB SLEEVE LIF ( I) NEEDLE ULTRA VERES 120MM LIF || ( I) TUBING INSUFFLAT SET W/0 R ING ADAPTOR LIF || (I) DRAPE VIDEO CAMERA 13cm X 244 em LIF || ( I ) DRAPE LAP ABDOM W/POUCH 1 02" X 1 22" X 78" STD SMS || (2) LEGGINGS W/7" CUFF 30'' X 42" ( I ) SAFETY SCALP EL # II S/STEEL || ( I ) GOWN IMPERV. XTRA REINF. XL T/WRAP LEVEL III ( I ) TABLE COY ER REINFORCED 50" X 90" LIF || (4) DRAPE UTILITY WIT APE LIF || (2) DRAPE SI-IEET 42" X 57" SMS || (I) TUBE SUCTION CONNECT Y." X 1 2' LIF || ( I ) MAYO STAND COYER REINFORCED LIF (1 0) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (4) TOWELS ABSORBENT 1 5" X 20" LIF || (2) LITE GLOVE || ( I ) DRAPE UNDERBUTTOCK W/ PO UCl-144" X 35" (2) SYRINGE I Occ W/0 NEEDLE LILOCK LIF || (2) SPEC IMEN CONTA INER 4oz W/LID & LABEL (1 5) LAP SPONGE PREWASH 18'' X 1 8" XRD LIF || ( I ) PVP PAINT 8" STICK SPONGE || ( I ) UTILITY BOWL QUART 32oz LIF ( I ) ELECTRODE DUAL DEPRES || ( I) DRESSING OPSITE POST PO 2!12 X 2" || ( I ) MERLINO SK IN PREP APPLIC. 39ML LIF || (3) GOWM XL SMS IMPERVIOUS REINFORCED LIF || ( I ) CORD LAPAROSCOPY MONOPOLAR FOOD SWICH ING || (1) FOLEY CATHETER KIT CONTAINING: || (I) CATHETER 1 6FR FOLEY 2WAY, Sec || (I) PYP TR IPLE SWABSTICK IODOPHOR (2) SWABSTICK DRY COTTON || ( I ) SYR I NGE IOcc WATERFREFIL LIF || (2) GLOVE MED FREETOUCH YYN I L P/F (I) TOWEL3PLYPOLY 17" X 18" || (I) DRAPE 4" FENESTRATED 18" X 26" (I) LABEL lD PATIENT || (I) JELLY LUBRI CATING FIVE GRAM || ( I ) URINARY BAG DRAINAGE 2000ML ANTI-REFLUX LIF ( I ) TRAY SBS || ( I ) WRAPPER 24" X 24" || Product Usage: || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
  • Manufacturer
  • 1 Event

Fabricante

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

331 dispositivos con un nombre similar

Más información acerca de la data acá

  • 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
  • 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
  • Modelo / Serial
    LOTS: SL15210 (150719663) 31-JUL-16 SL15244 (150820222) 31-AUG-16
  • Clasificación del producto
  • 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
  • Modelo / Serial
    LOT: SL15209 (150719960) 31-JUL-16
  • Clasificación del producto
  • 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
  • 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
  • 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
  • Modelo / Serial
    Catalog Number: 900012 LOTS: SL15202 (150719606) 31-JUL-16 SL15210 (150720034) 31-JUL-16 SL15219 (150720056) 31-JUL-16
  • Clasificación del producto
  • 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
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