Devices

Device Recall Customed

  • Modèle / numéro de série
    Product code 900-1408, 7 lots: 113015546 113057835 140211780 140412600 140513084 113047152 112051753
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    UMBILICAL VESSEL CATHETER KIT - CUSTOMED- || (1) PAPER TAPE MEASURE DISP. 24" || (1) FENESTRATED DRAPE 18" x 26" LIF || (1) NEEDLE HOLDER BAUMGARTNER 5" || (2) HALSTED MOSQUITO CVD 5" SERRAT || (1) ADSON FORCEP TISS. Wff || (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF || (6) GAUZE SPONGE 2" X 2" 8PL Y || (6) GAUZE 4" X 4" 16PL Y || (1) SYRINGE 1 cc TB SffiP || (1) IRIS FORCEP SERR Y. CVD 4" WITH PROTECTOR TIP || (1) NEEDLE WITH FILTER 18 X 1 Y. BLUNTffiP || (1) SUTURE 3-0 BLK MONOFIL || (1) TRAY ORGANIZER FULL DEEP || (1) WRAPPER 30" X 30" L/F || (1) PVP TRIPLE IODOPHOR SWABSTICK || (1) TONGUE DEPRESSOR 6" WOOD || (1) IRIS SCISSOR STRAIGHT 4 Y. W/PROTECTOR TIP || (1) SCALPEL WITH HANDLE #11 || (1) MOSQUITO FORCEP STRAIGHT 5" || (2) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK LIF || (2) 3 PLY POLY TOWEL || (1) UMBILICAL TAPE || (1 ) PROBE GRONED & DISNEETNS 6" 2ML || (1) EYE DRESSING EXT FINE POINT FULL || (2) NEEDLE WITH FILTER 18 X 1 Y. NOKOR PO || (1) PLASTIC TRAY 2/COMPARTMENT || (1) HALF TRAY || (1) STOPCOCK 3 WAY LUER SLIP || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
  • Manufacturer
    Customed, Inc
  • 1 Event

Fabricant

Customed, Inc
  • Adresse du fabricant
    Customed, Inc, Calle Igualdad Final #7, Fajardo PR 00738
  • Société-mère du fabricant (2017)
    Customed Inc
  • Source
    USFDA

331 dispositifs médicaux avec un nom similaire

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Device Recall Customed
  • Modèle / numéro de série
    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
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Description du dispositif
    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
  • Modèle / numéro de série
    LOTS: SL15210 (150719663) 31-JUL-16 SL15244 (150820222) 31-AUG-16
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Description du dispositif
    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
  • Modèle / numéro de série
    LOT: SL15209 (150719960) 31-JUL-16
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Description du dispositif
    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
  • Modèle / numéro de série
    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
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Description du dispositif
    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
  • Modèle / numéro de série
    Catalog Number: 900012 LOTS: SL15202 (150719606) 31-JUL-16 SL15210 (150720034) 31-JUL-16 SL15219 (150720056) 31-JUL-16
  • Classification du dispositif
    Obstetrical and Gynecological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Description du dispositif
    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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