Devices

Device Recall Customed

  • Model / Serial
    Product code 900-1408, 7 lots: 113015546 113057835 140211780 140412600 140513084 113047152 112051753
  • Product Classification
    General and Plastic Surgery 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
    UMBILICAL VESSEL CATHETER KIT - CUSTOMED- || (1) PAPER TAPE MEASURE DISP. 24" || (1) FENESTRATED DRAPE 18" x 26" LIF || (1) NEEDLE HOLDER BAUMGARTNER 5" || (2) HALSTED MOSQUITO CVD 5" SERRAT || (1) ADSON FORCEP TISS. Wff || (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF || (6) GAUZE SPONGE 2" X 2" 8PL Y || (6) GAUZE 4" X 4" 16PL Y || (1) SYRINGE 1 cc TB SffiP || (1) IRIS FORCEP SERR Y. CVD 4" WITH PROTECTOR TIP || (1) NEEDLE WITH FILTER 18 X 1 Y. BLUNTffiP || (1) SUTURE 3-0 BLK MONOFIL || (1) TRAY ORGANIZER FULL DEEP || (1) WRAPPER 30" X 30" L/F || (1) PVP TRIPLE IODOPHOR SWABSTICK || (1) TONGUE DEPRESSOR 6" WOOD || (1) IRIS SCISSOR STRAIGHT 4 Y. W/PROTECTOR TIP || (1) SCALPEL WITH HANDLE #11 || (1) MOSQUITO FORCEP STRAIGHT 5" || (2) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK LIF || (2) 3 PLY POLY TOWEL || (1) UMBILICAL TAPE || (1 ) PROBE GRONED & DISNEETNS 6" 2ML || (1) EYE DRESSING EXT FINE POINT FULL || (2) NEEDLE WITH FILTER 18 X 1 Y. NOKOR PO || (1) PLASTIC TRAY 2/COMPARTMENT || (1) HALF TRAY || (1) STOPCOCK 3 WAY LUER SLIP || 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: SL15202 (150719846) 31-JUL-16 SL15203 (150719846) 31-JUL-16 SL15229 (150820299) 31-AUG-16 SL15231 (150820299) 31-AUG-16
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Product Description
    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
  • Model / Serial
    LOTS: SL15212 (150719962) 31-JUL-16 SL15274 (150920990) 30-JUN-16 SL15274 (150920989) 30-SEP-16
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Product Description
    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
  • Model / Serial
    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
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Product Description
    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
  • Model / Serial
    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
  • Product Classification
    Cardiovascular Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Product Description
    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
  • Model / Serial
    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
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Product Description
    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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