Devices

Device Recall Customed

  • Modèle / numéro de série
    Product code 900-2423 ,3 lots 131010019 140111210 140312131
  • Classification du dispositif
    Ear, Nose, and Throat 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
    EAR PACK || CONTENTS: || (I) CAUTERY PENC IL ROCKER SW I TI-I CH ( I ) EMESIS BASIN l Oin 700cc || (2) LABEL FOR SKIN MARKERS || ( I) NEEDLE HYPODERMIC 1 80 X I Y, || ( I) WASI-l BASIN ROUND 6QT || (I) INSTRUMENT POUCH 7 X I I 2 COMPART || (I) STRIP STER I CLOSURE W' X 4" LIF || (I) SYRINGE 3cc W/0 NEEDLE LILOCK L/F (2) SY RI NGE I ML W/0 NEEDLE LILOCK LIF ( I ) CAUTERY POLISHER TI P LIF || ( I) SH EET ENT SPLIT 11 0 X 77 || (2) LITE GLOVE || (2) NEEDLE H YPODERM IC 27G X I \!..'' || (1 2) TOWELS CLOTH HUCK (BLUE) || ( I ) TUBE SUCTION CONNECT.'!." X 12' L/F ( I ) EAR ULCER SYRINGE 2oz LIF || ( I ) TABLE COYER REINFORCED 50" X 90" LIF ( I ) UTILITY BOWL 1 6oz LIF || (4) COTrON APPLICATOR 6" WOOD || ( I ) INSTRUMENT WIPE I MM 8.25 X 8.25 || ( I ) MAYO STAND COYER REINFORCED LIF || ( I ) NEEDLE & BLADE COUNTER 20c FOAM/MAG LIF ( I ) SKIN MARK ER W/R ULER || ( I ) SYRINGE IOcc W/0 NEEDLE LILOCK LIF || ( I ) TRAY MAYO SMALL || ( I ) SYRING E IOcc TI P CONTROL LILOCK LIF || ( I ) DRAPE MICROSCOPE ZEI SS || ( I ) TOWELS ABSORBENT 1 5'' X 20" LIF || ( I ) TIME OUT BEACON NON WOV EN ST LIF || ( I ) BLADE M INUATURE CARBON STEEL || ( I 0) GAUZE SPONGE 4" X 4" 1 6PLY XRD LIF || ( I ) NEEDLE BLUNT FI LL 1 80 X I Y, || (2) SCALPEL SAFETY WEIGHTED # 1 5 || ( I ) GOWN SURG, I MP ER. M I CROCOOL LG E (2) GOWN XL SURG ICAL MICROCOOL || ( I ) MERLINO SKIN PREP APPLIC. 39ML LIF || ( I ) WRAPPER 24" X 24" || WET SKIN PACK CONTA INING: ( I ) WRAPPER 30" X 30" || ( I ) TRAY 3/COMPARTM ENT || ( I ) PYP SCRUB SOLUTI ON 4oz. BOTrLE || (3) TI P ABSORBENT APPLICATOR STICK SPONGE || (3) TOWELS ABSORBENT 15" X 20" L/F (6) SPONGE WING SMALL LIF || (2) GLOVE MED FREETOUCI-1 VYN I L P/F || (2) COTrON APPLICATOR 6" WOOD || 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

En savoir plus sur les données ici

Device Recall Customed
  • Modèle / numéro de série
    LOTS: SL15202 (150719846) 31-JUL-16 SL15203 (150719846) 31-JUL-16 SL15229 (150820299) 31-AUG-16 SL15231 (150820299) 31-AUG-16
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Description du dispositif
    Catalog Number: 9002609 || ARTHOSCOPY 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: SL15212 (150719962) 31-JUL-16 SL15274 (150920990) 30-JUN-16 SL15274 (150920989) 30-SEP-16
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Description du dispositif
    Catalog Number: 9002614 || HIP AND KNEE REPLACEMENT 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: SL15181 (150619402) 30-JUN-16 SL15184 (150619402) 30-JUN-16 SL15184 (150619265) 30-JUN-16 SL15274 (150820300) 30-SEP-16 SL15275 (150820301) 30-SEP-16 SL15275 (150820300) 30-SEP-16
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Description du dispositif
    Catalog Number: 9002615 || EXTREMITY 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: SL15177 (150619477) 30-JUN-16 SL15181 (150619477) 30-JUN-16 SL15212 (150719843) 31-JUL-16 SL15215 (150719843) 31-JUL-16 SL15219 (150719843) 31-JUL-16 SL15271 (150920812) 30-SEP-16
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Description du dispositif
    Catalog Number: 9002618 || OPEN HEART 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: SL15201-02 (150619403) 31-JUL-16 SL15201-02 (150619266) 31-JUL-16 SL15202 (150619403) 31-JUL-16 SL15208 (150619403) 31-JUL-16 SL15232 (150820302) 31-AUG-16 SL15243 (150820302) 31-AUG-16 SL15246 (150820303) 31-AUG-16 SL15251 (150820303) 31-AUG-16
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Description du dispositif
    Catalog Number: 9002726 || HIP AND KNEE REPLACEMENT 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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