Devices

Device Recall Customed

  • Model / Serial
    Product code 900-660, 47 lots: 110061532 110071635 110071853 110102449 110112671 110122899 111010148 111020375 111030650 111040914 111051212 111061560 111071832 111082224 111092400 111102775 111112949 111123281 112010195 112020516 112030737 112041345 112052004 112062504 112083440 112093591 112093732 112114595 112125107 113015698 113025966 113036597 113036730 113057500 113057875 113068179 113088883 113099295 113109867 131110270 131110412 131110589 131210972 140111453 140211677 140211945 140513352
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • 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
    CESAREAN PACK- - || (3) ABSORBENT TOWELS 15" x 20" LIF || (1) PLASTIC BOWL WITH LID 80oz. || (1 0) LAP SPONGES PRE-WASH 18" x 18" XRD || (2) PAD OBSTETRICAL X-LARGE ST. || (1) MAYO STAND COVER REINFORCED LIF || (1) DRAPE SHEET 41" x 58" SMS LIF || (2) TUBE SUCTION CONNECT. Y.." X 12' LIF || (1) EAR ULCER SYRINGE 2oz. LIF || (1) YANKAUER SUCTION TUBE WITHOUT VENT L/F || (1) UMBILICAL CORD CLAMP || (1) SURGICAL BLADE #20 CARBON STEEL || (1) TABLE COVER REINFORCED 50" X 90" LIF || (1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS LIF || (1) DRESSING ISLAND 4" X 1 0" || (1) C-SECTION DRAPE WITH POUCH 102" X 121" X 78" || (1) BABY BLANKET PRINTED || (1) GOWN IMPERVIOUS REINFORCED LARGE SMS || (1) BAG SUTURE FLORAL || 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