Devices

Device Recall Customed

  • Modèle / numéro de série
    Product code 900-2614, 1 lot: 140312137
  • 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
    Hip & Knee replacement pack, 900-2614, contains || (1) CAUTERY TIP POLISHER UF || (1) BAG SUTURE FLORAL || (1) TUBE SUCTION CONNECT Y." X 12' UF || (1) TABLE COVER REINFORCED 50" X 90" UF || (1) MAYO STAND COVER REINFORCED UF || (5) TOWELS ABSORBENT 15" X 20" UF || (2) DRAPE SHEET 70" X 100" L/F || (5) LAP SPONGE PREWASH 18" X 18" XRD LIF || (1) SKIN STAPLE 35 WIDE LIF || (1) MAYO TRAY LARGE || (1) TOP DRAPE WITH ADHESIVE 100" X 50" SMS STD L/F || (1) BULB SYRINGE 60cc || (1) UTILITY BOWL 16oz || (1) UTILITY BOWL QUART 32oz || (1) INCISION DRAPE 23" X 17" || (1) SKIN MARKER WITH RULER || (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6 X 21 || (1) YANKAUER SUCTION TUBE WITHOUT VENT UF || (1) MERLING SKIN PREP APPLIC. 39ML UF || (1) BLADE SURGICAL# 10 STAINLESS STEEL || (1) SHEET SPLIT WITH ADHESIVE 108" X 77" UF || (1) *GLOVE# 7.5 SURGEON NEUTRALON LATEX || (1) * GLOVE # 8 SURGEON NEUTRALON LATEX || (1) *GLOVE# 8.5 SURGEON NEUTRALON LATEX || (3) GOWN IMPERVIOUS EXTRA REINFORCED XL LIF || (1) GOWN IMPERVIOUS EXTRA REINFORCED LARGE TOWEL & WRAP || (4) UTILITY DRAPE WITH TAPE UF || (1 0) GAUZE SPONGE 4" X4" 16PL Y XRD LIF || (2) BANDAGE ELASTIC WITH VELCRO 6" X 5yds || (1) BLADE SURGICAL# 20 STAINLESS STEEL || (2) LITE GLOVE UF || (1) STOCKINETIE IMPERVIOUS 12" X 48" || (1) CAUTERY PENCIL ROCKER SWITCH UF || (1) BANDAGE ESMARK 6" X 9yds 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

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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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