Devices

Device Recall Customed

  • Model / Serial
    Product code 900-170, 45 lots: 110102563 110112615 110123042 111010248 111020273 111041096 111051368 111061709 111071957 111082061 111082257 111092361 111092454 111102694 112010081 112020399 112030637 112041196 112051864 112062443 112072782 112093724 112125027 113015544 113025946 113026104 113036753 113047198 113057812 113068156 113078518 113088755 113089018 113089196 113099566 131110068 131110400 131110579 131210963 140111411 140211740 140312329 140412793 140513106 140513245
  • Product Classification
    Cardiovascular 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
    OPEN HEART TRAY - PACK- || (25) SPONGE LAP PREWASH 18" X 18" XRD L/F || (1) TRAY PLATO LARGE || (3) DRESSING NON ADH TELFA 8 X 3 || (2) BAG GLASSINE PLAIN || (2) YANKAUER SUCTION TUBE WITHOUT VENT LIF || (1) COVER TABLE REINFORCED 50" X 90" LIF || (1) NEEDLE HYPODERMIC 27G X 'h" || (4) COUNTER NEEDLE & BLADE 10c MAG/CLEAR || (2) SYRINGE 20cc WITHOUT NDL LUER LOCK LIF || (1) JAR 16oz 500cc GRADUATE MEASURE || (2) SYRINGE 30cc WITHOUT NDL LUER LOCK L/F || (2) PENCIL CAUTERY HAND SWITCHING LIF || (1) MARKER SKIN RULER || (2) BANDAGE ELASTIC 4" X 5yds LIF || (2) POLISHER CAUTERY TIP LIF || (2) BANDAGE ELASTIC 6" X 5yds LIF || (2) SYRINGE BULB 60cc CLEAR || (2) TUBE SUCTION CONNECT Y-t'' X 12' LIF || (1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF || (1) NEEDLE BLADE/KNIFE 3.0mm || (2) CONTAINER SPECIMEN 40z. WITH LID & LABEL || (1) BLADE SHARP ALL ARROUND || (1) BASIN EMESIS 10 IN 700cc || (3) CATHETER 20FR ROB NEL RED RUB || (3) BOWL UTILITY QUART 32oz LIF || (2) CATHETER THORACIC 32FR STRAIGH || (1) LABELS SET, HEPARINE, SALINE, ETC. || (2) SAFETY SCALPEL #10 DISP || (3) BASIN WASH ROUND 6QT (2) SAFETY SCALPEL #15 DISP || (2) BOWL UTILITY 16oz L/F || (1) WRAPPER 54" X 54" L/F || (1) CONNECTOR Y 3/8" X 3/8" X 3/8" || 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
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