Devices

Device Recall Customed

  • Model / Serial
    Product code 900-1202, 12 lots: 112051738 113078681 113099269 113109712 131110160 131210629 140111078 140211462 140211633 140311918 140412586 140513335
  • 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
    LAMINECTOMY PACK - || ( I) RING BASIN LIF || (2) TABLE COVER REINFORCED 50" X 90" LIF || ( I) SKIN MARKER INK W/8 LABEL || ( I) CAUTERY TIP POLISHER LIF || ( I) TUBE SUCTION CONNECT. W' X 12' LIF || (6) DRAPE UTILITY W/TAPE LIF || (I 0) GAUZE SPONGE 4" X 4" 16PL Y LIF || (2) UTILITY BOWL 16oz. LIF || ( IO) LAP SPONGE PRE-WASH XRD LIF || (2) SPECIMEN CONTAINER 4oz W/LID & LABEL || (2) MAYO STAND COVER REINFORCED LIF || ( I) GOWN SURG. REINF. XL TOWEL WRAP || (6) ABSORBENT TOWEL I5" X 20" LIF || ( I) DRAPE LAP 102" X 121" X 78" W/POUCI-1 SMS LIF || ( I) SURGICAL DURAPREP SOLUTION 26ML LIF || (6) DRAPE SHEET 41" X 69" MEDIUM LIF || (2) LEGGING W/7'' CUFF 30" X 42" LIF || (2) NEEDLE & BLADE COUNTER I Oc MAG /CLEAR || ( I) CAUTERY PENCIL PUSH BOTTOM LIF || ( I) BAG SUTURE FLORAL LIF || ( I) PVP SCRUB 8" STICK SPONGE || ( I) MAYO TRAY LARGE LIF || (I 0) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF || ( I) SURGICAL BLADE# I 0 CARBON STEEL || (2) BULB SYRINGE 60cc CLEAR LIF || ( I) SURGICAL BLADE# I I CARBON STEEL || ( I) SURGICAL BLADE # 15 CARBON STEEL || ( I) GOWN FABRIC REINFORCED SONTARA XL LIF || ( I) SYRINGE IOcc W/NDL 20G X I Y, LILOCK LIF || ( I) PVP PAINT 8" STICK SPONGE || ( I) SURGICAL STRIP W' X 6" COTTON || (2) LITE GLOVES LIF || 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: 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
Device Recall Customed
  • Model / Serial
    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
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Product Description
    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
    Customed, Inc
Device Recall Customed
  • Model / Serial
    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
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Product Description
    Catalog Number: 900028 LAPAROSCOPY SURGICAL PACK
  • Manufacturer
    Customed, Inc
Device Recall Customed
  • Model / Serial
    LOTS: SL15173 (150619057) 30-JUN-16 SL15174 (150619057) 30-JUN-16 SL15175 (150619057) 30-JUN-16 SL15209 (150719928) 31-JUL-16 SL15210 (150719928) 31-JUL-16 SL15216 (150719928) 31-JUL-16 SL15224 (150820057) 31-AUG-16 SL15229 (150820057) 31-AUG-16 SL15258 (150920726) 30-SEP-16 SL15259 (150920726) 30-SEP-16 SL15260 (150920726) 30-SEP-16
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Product Description
    Catalog Number: 900032 UNIVERSAL DRAINAGE TRAY || 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