Devices

Device Recall Customed

  • Modèle / numéro de série
    Product code 900-1587, 36 lots: 102030623 110082155 110082298 110102430 110112610 110122922 111010202 111020362 111030586 111040993 111051366 111061501 111071771 111082193 111092502 111102687 111113016 111123356 112010065 112020382 112041190 112051845 112062430 112072709 112083158 112083400 113015504 113025773 113036453 113036751 113067890 113089195 113099383 131110184 140111159 140312077
  • 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
    UNIVERSAL PACK - || (1) TRAY ORGANIZER FULL DEEP || (1) ANESTHESIA SPINAL NEEDLE 22G X 3 ~ UF || (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK UF || (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK UF || (1) NEEDLE HYPODERMIC 20G X 1 ~ UF || (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS AAMI Ill || (1) SHEET SPLIT WITH ADHESIVE 108" X 77" STD SMS LIF || (1) SHEET% 57" X 63" REINFORCED SMS LIF || (2) TOWELS ABSORBENT 15" X 20" LIF || (4) DRAPE UTILITY LIF || (1 0) GAUZE SPONGES 4" X 4" 12PL Y LIF || (4) CLOTH HUCK TOWELS BLUE LIF || (1) TABLE COVER REINFORCED 50" X 90" UF || (1) SCALPEL WITH HANDLE #11 || (1) DENTURE CUP WITH LID || (1) TRAY 2 COMPARTMENT || (2) ABSORBENT TIP APPLICATOR || (1) IMPERVIOUS STOCKINETIE 14" X 48" LIF || (1) TAPE TRANSPORE 1" X 36" || (1) DIISP NEEDLE 30 X ~ || (1) PROBE DRAPE 6" X 96 WITH GEL || (1) ARTERIAL NEEDLE 18 X 2 % || (1) CATHETER INTRODUCER 7FR || (1) NEEDLE & BLADE COUNTER 10c MAG/CLEAR L/F || 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

En savoir plus sur les données ici

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
326 en plus