Device Recall Customed

  • Modèle / numéro de série
    Product code 900-2234, 8 lots 112030726 113088792 113109792 131110112 131110338 140211660 140412835 140512993
  • Classification du dispositif
  • 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
    EAR PACK || CONTENTS: || ( I ) B LADE SU RG ICA L # 15 CARBON STEEL || ( I ) EMESI S BASIN lO in 700cc || ( I ) GOWN XL SMS IM P. REINFORCED || ( I ) NEEDLE HYPODERM IC 1 8G X I 'h || ( I ) WASH BASIN ROUND 6QT || ( I ) INSTRUMENT POUCH 7 X II 2COMPARTMENT || (I) STERI STR I P CLOSURE 'h" X 4" || ( I) SYRINGE 3cc WITHOUT NEEDLE LILOCK || (2) SYRINGE I ML WITHOUT NEEDLE LILOCK || (I) CAUTERY TIP POLISHER || (I) SHEET ENT SPLIT 110" X 77" SMS || ( I ) GOWN I MP XTRA REINF. SMS XLT/ W LEVEL I V || (2) LITE GLOVE || (1 2) TOWELS CLOTH HUCK (BLUE) || ( I ) TUBE SUCTION CONNECT W' X 1 2' || (I) EAR ULCER SYRINGE 2oz || (I) TABLE COYER REINFORCED 50" X 90" || ( I) UTILITY BOWL 16oz || (4) APPLICATOR COTTON 6" WOOD || (2) STRJPS TAPE 24" X 4" || ( I ) GOWN LGE SMS I MPERVIOUS REINFORCED ( I ) WIPE INSTRUMENT LMM 8.25 X 8.25 || ( I ) MAYO STAND COYER REINFORCED || ( I ) NEEDLE & BLADE COUNTER 20c FOAM/ MAG ( I ) SYRINGE I Occ WITHOUT NEEDLE LILOCK || ( I ) MAYOTRAY SMALL || ( I ) SYRINGE I Occ TI P CONTROL LUER LOCK ( I ) DRAPE M ICROCOSPE LE I CA 42 X 105 || ( I ) TI ME OUT BEACON NON WOVEN || (I) BLADE M IN IATURE CARBON STEEL || (10) GAUZE SPONGE 4" X 4" 1 6PLY XRD || (I) SK I N MARKER INK W/8 LABEL || (2) NEEDLE HYPODERM I C 27G X I W' || ONE PACK WET SK IN W ITH CONTENTS: || ( I ) WRAPPER SMS 30" X 30" || (2) COTTON TIP APPLICATOR 6" WOOD || (2) GLOVE MED FREETOUCH VYNIL P/F || (6) SPONGE W ING SMALL || (4) TOWELS ABSORBENT 1 5" X 20" || (3) TIP ABSORB. APPLICATOR STI CK SPONGE || ( I ) PVP IODOPHOR PAINT 4oz. BOTTLE || (I) PVP SCRUB SOLUTION 4oz. BOTTLE || (I) TRAY 3/COMPARTMENT || Product Usage: || 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
326 en plus