Devices

Device Recall Customed

  • Modèle / numéro de série
    Code 900-2903, 4 lots 113026303 113057705 113068034 113088858
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • 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
    ORTHOPEDIC IMPLANT || PACK CUSTOMED USA, CODE 900-2903 || CONTENTS: || (1) CAUTERY TIP POLISHER UF || (1) SKIN MARKER W/RULER || (1) BAG SUTURE FLORAL || (1) U - DRAPE 60" X 70" WITAPE SPLIT 6" X 21" || (1) TUBE SUCTION CONNECT W' X 12' UF || (2) PAD ABDOMINAL 8" X 7.5" || (1) BAG GLASSINE || (1) YANKAUER SUCTION TUBE W/0 VENT LIF || (2) LITE GLOVE UF || (1) SOLUTION SURGICAL DURAPREP 26ML LIF || (2) TABLE COVER REINFORCED 50" X 90" LIF || (1) BLADE SURGICAL# 10 STAINLESS STEEL || (1) MAYO STAND COVER REINFORCED LIF || (1) SHEET SPLIT W/ADHES 108" X 77" STD SMS L/F || (5) TOWELS ABSORBENT 15" X 20" UF || (1) STOKINETIE IMPERVIOUS 14" X 48" LIF || (2) DRAPE SHEET 70" X 100" LIF || (1) *GLOVE# 7'!h SURGEON NEUTRALON LATEX || (5) LAP SPONGE PREWASH 18" X 18" XRD LIF || (1) *GLOVE # 8 SURGEON NEUTRALON LATEX || (1) SKIN STAPLE 35 WIDE UF || (1) *GLOVE# 8'!h SURGEON NEUTRALON LATEX || (1) TRAY MAYO LGE || (1) GOWN SURG REINFORCED XL TOWEUWRAP || (1) DRAPE TOP W/ADHES 108" X 50" STD SMS UF || (2) GOWN XL SMS IMPERVIOUS REINFORCED UF || (1) BULB SYRINGE 60cc CLEAR || (1) CAUTERY PENCYL ROCKER SWITCH UF || (1) UTILITY BOWL 16oz LIF || (1) BLADE SURGICAL# 20 STAINLESS STEEL || (1) UTILITY BOWL QUART 32oz LIF || (4) DRAPE UTILITY WITAPE UF || (1) DRAPE INCISION 23" X 17" UF || Product Usage: || 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
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