Device Recall Customed

  • Modelo / Serial
    Code 900-3025, 1 lot: 131110114
  • 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
    Chole Cystectomy All Endo System , code 900-3025, contains: || (1) TABLE COVER 44X 90 UF || (1) SYRINGE 20ccW/O NDL LUER LOCK LIF || (2) MAYO STAND COVER REINFORCED UF || (1) NEEDLE HYPODERMIC || (6) ABSORBENT TOWEL 15 X 20 UF || (1) NEEDLE HYPODERMIC 22G X 1Y. UF || (4) UTILITY DRAPE WIT APE UF || (1) TROCAR DILATING XCELL 5MM X 100 || (3) GOWN XL SURGICAL MICROCOOL L/F || (1) TROCAR ENDOPATH XCEL DILATING TIP || (1) WRAPPER 24" X 24" UF || (1) TUBING INSUFFLATING OPEN TIP W/0 VENT UF || (1) DRAPE LAP ABDO. W/POUCH 102 X 122 X 78 STD UF || (5) APPLICATOR COTTON 6 WOOD UF || (1) ULTRA VERES NEEDLE 120MM LIF || (1) APPLIER MUL Tl CLIP W/SHAF GUN || (1) SPECIMEN CONTAINER 4oz. W/LID & LABEL UF || (2) DRAPE :Y. ECONOMY 53" X 77" UF || (2) UTLITY BOWL 16oz. UF || (1) SCALPEL WEIGHTED SAFETY #11 UF || (1) RING BASIN || (1) TIME OUT BEACON NON WOVEN UF || (1) TUBE SUCTION CONNECT || (1) MERLING SKIN PREP APPLIC 39ML UF || (1 0) GAUZE SPONGE 4 X 4 16PL Y XRD LIF || (2) TOWEL CLOTH HUCK (BLUE) UF || (1 0) GAUZE SPONGE 4 X 4 16PL Y UF || (1) SCISSOR CURVED W/MONOPOLAR CAUTERY 5MM || (5) LAP SPONGE PRE-WASH 18" X 18" XRD UF || (1) DISSECTOR CURVED W/MONOPLAR CAUTERY 5MM || (1) SKIN MARKER INK W/8 LABEUTIMEOUT/RULER LIF || (2) LIGHT SHIELD UF || (1) SUTURE BAG FLORAL UF (4) DRESSING ISLAND 4 X 6 || (1) DRAPE LASER CAMERA W/ELASTIC 6X 96 || (1) PK. STERI STRIP CLOSURE || (1) NEEDLE & BLADE COUNT 60C FOAM STR/MAG STR UF || (1) MAYO TRAY SMALL || (1) SYRINGE 30ML SLIP TIP 1 ML UF || 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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