Devices

Device Recall Customed

  • Modelo / Serial
    Code 900-2718: 3 lots 113026299 113068033 113078728
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    Knee Arthroscopy Pack, code 900-2718, contains: || (1 0) GAUZE SPONGES 4 X 4 12PL Y || (2) PADDING CAST SOFT ROLL 6 X 4yds. || (1) GOBAN SELF-ADHERENT WRAP 6 X 5yds || (3) PAD ABDOMINAL 8 X 7.5 || (1) DRESSING 1 X 8 XEROFORM PETROLAT || (10) GAUZE SPONGES 4 X 4 16PLY XRD || (3) NEEDLE HYPODERMIC 18G X 1 || (1) NEEDLE SPINAL ANESTH 18G X 3 || (1) NEEDLE HYPODERMIC 22G X 1 || (1) SYRINGE 30cc W/0 NEEDLE LUER LOCK || (1) SCALPEL W/HANDLE 11 || (1) SKIN MARKER W/RULER || (9) LABELS FOR SKIN MARKERS || (1) RULER || (3) Pr. GLOVESURG 8 DERMA PRENE POWDER FREE || (1) BANDAGE ELASTIC KNIT STD 10yds || (1) BANDAGE ESMARK 6 X 9yds || (8) TOWELS CLOTH HUCK BLUE || (1) U - DRAPE 60 X 70 WIT APE SPLIT 6 X 21 || (1) SHEET 60 X 77 DRAPE REINFORCED || (2) SOLUTION SURGICAL DURAPREP 26ML || (3) TUBE SUCTION CONNECT || (1) BOWL UTILITY 16oz. || (1) COVER TABLE REINFORCED 50 X 90 || (2) GOWN SURGICAL REINFORCED X-LARGE || (1) GOWN SURGICAL REINFORCED X-LARGE T/WRAP || (2) TOWELS ABSORBENT 15X 20 || (1) STOCKINETTE IMPERV 12 X 48 || (2) BAG PLASTIC 6 X 12 || (1) KNEE ARTHROSCOPY DRAPE || (1) FILTER STRAW 5 MICRO || (2) LITE GLOVE || Product Usage: || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
  • Manufacturer
    Customed, Inc
  • 1 Event

Fabricante

Customed, Inc
  • Dirección del fabricante
    Customed, Inc, Calle Igualdad Final #7, Fajardo PR 00738
  • Empresa matriz del fabricante (2017)
    Customed Inc
  • Source
    USFDA

331 dispositivos con un nombre similar

Más información acerca de la data acá

Device Recall Customed
  • Modelo / Serial
    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
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed only in Puerto Rico.
  • Descripción del producto
    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
  • Modelo / Serial
    LOTS: SL15210 (150719663) 31-JUL-16 SL15244 (150820222) 31-AUG-16
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed only in Puerto Rico.
  • Descripción del producto
    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
  • Modelo / Serial
    LOT: SL15209 (150719960) 31-JUL-16
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed only in Puerto Rico.
  • Descripción del producto
    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
  • Modelo / Serial
    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
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distributed only in Puerto Rico.
  • Descripción del producto
    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
  • Modelo / Serial
    Catalog Number: 900012 LOTS: SL15202 (150719606) 31-JUL-16 SL15210 (150720034) 31-JUL-16 SL15219 (150720056) 31-JUL-16
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed only in Puerto Rico.
  • Descripción del producto
    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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