Device Recall Customed

  • Modèle / numéro de série
    Product code 900-357, 2 lots: 113099550 113109831
  • Classification du dispositif
  • 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
    OPHTALMIC PACK- (3) ABSORBENT TOWELS 15" X 20" LIF || (1) MAYO STAND COVER REINFORCED LIF || (1) OPHTALMIC DRAPE WITH POUCH LIF || (2) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF || (10) COTTON TIP APPLICATOR 6" WOOD || (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF || (2) NEEDLE HYPODERMIC 18G X 1 Y." || (1) NEEDLE HYPODERMIC 25G X 5/8" || (2) EYE PAD 2 1/8 X 2 5/8 UF || (5) EYE SPEAR MICRO SPONGE || (2) LITE GLOVE LIF || (1) CABLE BIPOLAR || (1) EYE SHIELD UNIVERSAL || (1) OPHTALMIC PENCIL BIPOLAR || (1) IV ADM. SET 15 DROPS 106" LONG L/F || (1) TABLE COVER REINFORCED 50" X 90" UF || (1) KNIFE/BLADE MIN. EDGE ROUND || (1) KNIFE 15 5.0 CONTROLLED || (1) PLASTIC TRAY 3/COMPARTMENT || (1)KNIFE 3.2MM ANGLE BEVEL UP || (1) CYSTOTOMO IRRIG. 25GA X5/8 || (1) MAYO TRAY LARGE || (2) GOWN STANDARD LARGE SMS STD VELCRO NECK || (1) PVP PAINT 8" STICK SPONGE || (1) NEEDLE & BLADE COUNTER 30c MAG/MAG/LF || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Customed, Inc, Calle Igualdad Final #7, Fajardo PR 00738
  • Société-mère du fabricant (2017)
  • Source
    USFDA

331 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • 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
  • 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
  • Modèle / numéro de série
    LOTS: SL15210 (150719663) 31-JUL-16 SL15244 (150820222) 31-AUG-16
  • Classification du dispositif
  • 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
  • Modèle / numéro de série
    LOT: SL15209 (150719960) 31-JUL-16
  • Classification du dispositif
  • 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
  • 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
  • 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
  • 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
  • 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
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