Devices

Device Recall Customed

  • Modèle / numéro de série
    Code 900-2917, 6 lots 113047022 113057702 113068036 113078732 113109798 140312146
  • Classification du dispositif
    Neurological 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
    ACDFPACK || SURGICAL CENTER, CODE 900-2917. || CONTENTS: || (1) SOLUTION SURGICAL DURAPREP 6ML LIF || (4) Prs. GLOVE SURG. DERMA PRENE # 8 PF LIF || (3) GOWN SOFT SMS STD XL SET IN SLEEVE LIF || (3) TOWELS ABSORBEN 15" X 20" UF || (1) TABLE COVER REINFORCED 50" X 90" L/F || (1) MAYO STAND COVER REINFORCED LIF || (2) DRAPE o/.. 60" X 76" REINFORCED LIF || (1)DRAPE THYROID 100" X 142" X 72" LIF || (1) FLUORO COVER 30" X 30" W/RUBBAND L/F || (1) DRAPE INCISE IOBAN 13" X 13" || (2) LITE GLOVE LIF || (2) TUBE SUCTION CONNECT. W X 12' LIF || (12) TOWELS CLOTH HUCK BLUE LIF || (1) UTILITY BOWL 16oz LIF || (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF || (5) LAP SPONGE PREWASH 18" X 18" XRD LIF || (1) SKIN MARKER W/RULER LIF || (9) LABELS FOR SKIN MARKERS 1.25 X Y:! || (1) RULER || (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG LIF || (2) SYRINGE 20cc W/0 NDL LUER LOCK LIF || (2) SYRINGE 3cc W/0 NDL LUER LOCK LIF || (1) BULB SYRINGE 60cc LIF || (3) NEEDLE HYPODERMIC 18G X 1Y:! LIF || (1) NEEDLE 30G X 1 DISP. L/F || (1) NEEDLE SPINAL ANESTH 18G X 3W' LIF || (2) BLADE SURGICAL# 15 CARBON STEEL || (1) TIME OUT BEACON NON WOVEN LIF || (2) TAPE TEGADERM 2 3/8 "X 2 o/.. "L/F || (2) MEDICINE CUP 2oz LIF || 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: 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
Device Recall Customed
  • Modèle / numéro de série
    LOTS: SL15180 (150619409) 31-MAY-16 SL15181 (150619409) 31-MAY-16 SL15197 (150719607) 31-MAY-16 SL15201-01 (150719607) 31-MAY-16 SL15230 (150820136) 31-AUG-16 SL15251 (150820136) 31-AUG-16 SL15265 (150920652) 30-SEP-16 SL15266 (150920652) 30-SEP-16
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Description du dispositif
    Catalog Number: 900020 IRRIGATION TRAY WITH IRRIGATION BULB SYRINGE || 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: SL15194 (150719926) 31-JUL-16 SL15194 (150719927) 31-JUL-16 SL15195-02 (150719927) 31-JUL-16 SL15195-02 (150719926) 31-JUL-16 SL15258 (150719926) 31-JUL-16 SL15258 (150719927) 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: 900028 LAPAROSCOPY SURGICAL PACK
  • Manufacturer
    Customed, Inc
Device Recall Customed
  • Modèle / numéro de série
    LOTS: SL15173 (150619057) 30-JUN-16 SL15174 (150619057) 30-JUN-16 SL15175 (150619057) 30-JUN-16 SL15209 (150719928) 31-JUL-16 SL15210 (150719928) 31-JUL-16 SL15216 (150719928) 31-JUL-16 SL15224 (150820057) 31-AUG-16 SL15229 (150820057) 31-AUG-16 SL15258 (150920726) 30-SEP-16 SL15259 (150920726) 30-SEP-16 SL15260 (150920726) 30-SEP-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: 900032 UNIVERSAL DRAINAGE TRAY || 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