Device Recall Customed

  • Modèle / numéro de série
    Product code 900-169, 8 lots: 111010061 111040963 111071906 112041402 112051862 113036593 113046891 113088753
  • 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
    Universal Pack- - || (1) TABLE COVER REINFORCED 50" X 90" LIF || (3) TOWEL ABSORBENT 15" X 20" LIF || (1) MAYO STAND COVER REINFORCED LIF || (1) TUBE SUCTION CONNECT. X" X 12' LIF || (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF || (1) BAG SUTURE FLORAL || (1) DRAPE TOP WITH ADHESIVE 100" X 53" LIF || (1) DRAPE BOTTOM ASS REINFORCED 71" X 71" WITH TAPE LIF || (1) CAUTERY TIP POLISHER LIF || (3) SURGICAL BLADE #1 0 CARBON STEEL || (15) LAP SPONGE PREWASH XRD LIF || (1) BAG GLASSINE || (2) DRAPE SIDE WITH ADHESIVE 36" X 77" || (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR L/F || (1) LITES GLOVE LIF || (3) SURGICAL BLADE #15 CARBON STEEL || (1) SPECIMEN CONTAINER 4oz WITH LID & LABEL || (1) WRAPPER 24" X 24" || (3) GOWN SURG SMS POLY-REINF. BREATHABLE IMP XLGE AAMI IV || 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: SL15169 (150619380) 30-JUN-16 SL15174 (150619380) 30-JUN-16 SL15201-01 (150719634) 31-JUL-16 SL15212 (150720070) 31-JUL-16 SL15212 (150720071) 31-JUL-16 SL15272 (150920769) 30-SEP-16 SL15273 (150920769) 30-SEP-16
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Description du dispositif
    Catalog Number: 9001297 || PREMIUM OBSTETRICAL 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
  • 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
  • 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
  • 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
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Description du dispositif
    Catalog Number: 900028 LAPAROSCOPY SURGICAL PACK
  • Manufacturer
326 en plus