Devices

Device Recall Customed

  • Model / Serial
    Product code 900-1496, 22 lots: 112041078 112051677 112062422 112114953 113015550 113025817 113026047 113036320 113036750 113057690 113067952 113088734 113099274 113109735 131110178 131210749 140111077 140211644 140311921 140412602 140513092 140513391
  • Product Classification
    Gastroenterology-Urology 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
    D & C LAPAROSCOPY PACK - || (1) TUBING INSUFFLATION OPEN TIP WITHOUT VENT || (1) MAYO STAND COVER REINFORCED UF || (4) DRAPE UTILITY UF || (1) TRAY MAYO SMALL LIF || (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL || (1) SUTURE BAG FLORAL LIF || (1) TUBE SUCTION CONNECT X" X 12' LIF || (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF || (2) LEGGINGS WITH 7" CUFF 30" X 42" LIF || (1) UTILITY BOWL 32oz. UF || (1) *FOLEY CATHETER 5CC/2 WAY 16FR SILICONE COATED LATEX || (2) DRESSING NON ADH TELFA 4 X 3 ST. UF || (1) JELLY LUBRICATING FIVE GRAM || (1) TABLE COVER REINFORCED 50" X 90" LIF || (1) *Pk. STERI STRIP LAP SET LATEX || (1) COVER CAMERA W/ELAST UF || (2) GOWN LARGE SMS IMPERVIOUS REINFORCED UF || (4) TOWELS ABSORBENT 15" X 20" UF || (1) DRAPE LAP. PERINEAL WITH POUCH 102" X 97" SOFT SMS UF || (2) LIGHT SHIELD || (1) DRESSING TEGADERM 4" X 4 %" LIF || (10) GAUZE SPONGE 4" X 4" 16PLY XRD UF || (1) GOWN SURG. REINFORCED X-LARGE TOWEL/WRAP || (1) SCALPEL WEIGHTED SAFETY #11 || (1) BAG ZIP LOCK || (1) Pk. STRIP STERI CLOSURE W' X 4" LIF || (1) TIME OUT BEACON NON WOVEN ST. UF || (1) BANDAGE GAUZE STRETCH 4" || (1) NEEDLE ULTRA VERES 120MM UF || (2) COUNTER NDUBLADE, 10C MAG/CLEAR UF || (1) SKIN MARKER INK WITH 8 LABEL !TIME OUT/RULER L/F || 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
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