Devices

Device Recall Customed

  • Model / Serial
    Product code 900-1476, 12 lots: 112030618 112072885 112104097 112114378 112114555 112124949 113015689 113047329 113078255 113088832 113089191 121104357
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    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.
  • Product Description
    IMPLANTE DE ORTHOPEDIA - || ( I) CAUTERY T IP POLI SHER LIF || ( I) BAG SUTURE FLORAL LIF || ( I) TUBE SUCTION CONNECT \14'' X 12' LIF || ( I) BAG GLASSINE LIF || (2) LITE GLOVE LIF || (2) TABLE COVER 50" X 90" REINFORCED LIF || ( I) MAYO STAND COVER REINFORCED LIF || (5) TOWEL ABSORBENT 15" X 20" LIF || (4) DRAPE UTILITY WITH TAPE LIF || (2) DRAPE SHEET 70" X I 00" LIF || (5) LAP SPONGES PRE-WASH 18" X 18" XRD L/F || ( I) MAYO TRAY LARGE LIF || ( I) DRAPE TOP WITH ADHESIVE LIF || ( I) SKIN STAPLE 35 WIDE LIF || ( I) BULB SYRINGE 60cc LIF || ( I) UTILITY BOWL 16oz L/F || (2) UTILITY BOWL 32oz L/F || ( I) INCISION DRAPE 23" X I 7" L/F || (I) SKIN MARKER WITH RULER LIF || ( I) U-DRAPE 54" X 72" W/TAPE SPLIT 6" X 2 1" LIF || (2) ABDOMINAL PAD 8" X 7.5" L/F || ( I) YANKAUER SUCTION TUBE W/0 VENT L/F || (I) DURAPREP SURGICAL SOLUTION 26ML LIF || ( I) SURGICAL BLADE # 10 STAINLESS STEEL || (I) SPLIT SHEET W/ADH 108" X 77"" STD SMS LIF || ( I) IMP. STOCKINETTE LIF || (I) *Pr. SURGEON NEUTRALON GLOVE #7 ~ LATEX || ( I) *Pr. SURGEON NEUTRALON GLOVE #8 LATEX || (I) *Pr. SURGEON NEUTRALON GLOVE #8 ~ LATEX || (I) SURGEON GOWN REINF. T/WRAP X-LARGE LIF || (2) IMP. GOWN REINFORCED X-LARGE SMS LIF || (I) PENCIL CAUTERY ROCKER SWITCH LIF || (I) SURGICAL BLADE #20 STAINLESS STEEL || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
  • Manufacturer
    Customed, Inc
  • 1 Event

Manufacturer

Customed, Inc
  • Manufacturer Address
    Customed, Inc, Calle Igualdad Final #7, Fajardo PR 00738
  • Manufacturer Parent Company (2017)
    Customed Inc
  • Source
    USFDA

331 devices with a similar name

Learn more about the data here

Device Recall Customed
  • Model / 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
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Product Description
    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
  • Model / Serial
    LOTS: SL15210 (150719663) 31-JUL-16 SL15244 (150820222) 31-AUG-16
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Product Description
    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
  • Model / Serial
    LOT: SL15209 (150719960) 31-JUL-16
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Product Description
    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
  • Model / 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
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Product Description
    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
  • Model / Serial
    Catalog Number: 900012 LOTS: SL15202 (150719606) 31-JUL-16 SL15210 (150720034) 31-JUL-16 SL15219 (150720056) 31-JUL-16
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Product Description
    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
326 more