Devices

Device Recall Customed

  • Modèle / numéro de série
    Product code 900-345, 38 lots: 109122917 110020470 110030770 110040936 110071690 110092240 110112640 111010116 111030655 111051294 111051326 111071845 111082215 111092537 111102740 111113101 111123239 112010162 112030866 112051977 112093937 112104306 112124703 112124858 113025959 113036353 113046956 113067922 113088810 113089162 113109830 131210950 140211466 140312155 140412559 140513144 140513338 140613746
  • 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
    BASIC PACK W/OUT GOWN- || (1) TABLE COVER REINFORCED 50" X 90" UF || (4) DRAPE UTILITY WITH TAPE UF || (1) TOWEL ABSORBENT 15" x 20" L/F || (1) SUTURE BAG FLORAL || (1) DRAPE SHEET 42" X 57" SMS || g~ SHEET o/. 57" X 63" REINFORCED SMS UF || MAYO STAND COVER REINFORCED UF || 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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