Devices

Device Recall Customed

  • Model / Serial
    Product code 900-1176, 21 lots: 112051673 112051735 112062336 112083210 112093723 112114597 112114925 113025928 113036747 113078239 113078679 113089017 113099562 140111074 140211461 140211717 140312052 140312421 140412913 140513071 140513476
  • 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
    LAP AROSCOPY PACK - || (10) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF || (1) MAYO STAND COVER REINFORCED L/F || (4) ADHESIVE BANDAGE%" X 3" ST. LIF || (1) TABLE COVER REINFORCED 50" X 90" LIF || (2) GOWN IMPERVIOUS REINFORCED LARGE SMS || (2) TOWEL ABSORBENT 15" X 20" LIF || (1) DRAPE LASER CAMERA W/EL 6" X 96" LIF || (2) LITE GLOVE LIF || (1) TUBE SUCTION CONNECTING W X 12' LIF || (1) DRAPE LAP WITH POUCH 102" X 121 " X 78" STD SMS || (1) BLADE SURGICAL #11 STAINLESS STEEL || (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF || (4) DRAPE UTILITY WITH TAPE L/F || (1) BAG SUTURE FLORAL || (1) TUR Y SET, 2 LEAD L/F || (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR LIF || (1) GOWN STANDARD LARGE SMS VELCRO NECK || (1) TUBE SUCTION CONNECT 3/16" X 12' LIF || (1) Pk. STERI STRIP LAP. LATEX || (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL || (1) CAUTERY PENCIL ROCKER SWITCH 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

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Device Recall Customed
  • Model / Serial
    Product code 900-002, 26 lots: 112020289 112030605 112041383 112051709 112061653 112062296 112072757 112093974 112104120 112124901 113015421 113015629 113026199 113036745 113057404 113057683 113068134 113078451 113078655 113099260 131110394 131110574 140211618 140211908 140513048 140613547
  • Product Classification
    Cardiovascular 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
    Customed Angiodrape Pack || convenience pack include multiple components: syringe 10cc and 30cc, gauze, denture cup, specimen container, band bag, glove, gown, needle hypodermic, absorbent towels, table cover, scalpel,cloth huck towel,iodine povidone,applicator sponge,towel clamp, femoral angiography drape,needle 18G,& Guidewire || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
  • Manufacturer
    Customed, Inc
Device Recall Customed
  • Model / Serial
    Product code 900-164, 14 lots: 110061393 113046935 113047213 113047335 113057700 113068153 113109743 131110191 131110600 140111164 140211648 140311924 140513392 140513453
  • 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
    Customed Femoral Pack , convenience pack include multiple components: Syringe 3cc, 5cc, 10cc, 20cc; swabstick chlorascrub, needles, gauze/sponges, table cover, absrobent towels, halsted Mosquito CVD, gown, bowls, wrapper, scalpel safety, Mosquito forcep, cloth huck, clamp towel, fluorocover, medicine cup, femoral angiodrape, mayo tray, counter & labels. || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
  • Manufacturer
    Customed, Inc
Device Recall Customed
  • Model / Serial
    Product code 900-012, 24 lots: 113036306 113015685 112030796 112041172 112062299 112083042 112051659 112093835 113046992 113047150 113015422 113057828 112124902 131110142 113089148 113099380 113078658 131210664 140111130 140211621 140311909 140412444 140513051 140613549
  • 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
    Customed O.B. Pack || convenience pack include multiple components: set up cover, absorbent towel, ear ulcer syringe, pad, umbilical cord clamp, wash basin, baby blankets, table cover, gauze sponge, syringe 10CC w/o needle & 10CC with needle, feeding tube, drape, legging with cuff, underbuttock drape, gown, container with lid, mayo tray, receiving blanket, & baby beannies. || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
  • Manufacturer
    Customed, Inc
Device Recall Customed
  • Model / Serial
    Product code 900-028, 30 lots: 111071871 112041386 112041433 112051660 112051712 112062301 112062560 112093834 112124408 112124903 112125312 113015686 113026162 113036772 113047331 113057830 113068022 113068136 113078564 113089015 113089177 113099559 131110062 131110395 131110575 140111089 140111447 140211739 140312327 140513052
  • 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
    Customed Laparoscopy convenience pack include multiple components: gowns, table covers, needle and blade counter, bag suture, suture, sponges/gauzes, containers, syringes 20cc & 30cc w/o needle, needle, drape, tubing, towel, dressing island, and blade surgical SS. || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
  • Manufacturer
    Customed, Inc
Device Recall Customed
  • Model / Serial
    Product code 900-036, 34 lots: 111113166 111123284 112010009 112010241 112020297 112030608 112041067 112051663 112062306 112062580 112072761 112093837 112114906 113015423 113025923 113026201 113036746 113057376 113057765 113068023 113068137 113078565 113089178 113099560 131110082 131110396 131110576 131210954 140111448 140211910 140312429 140412881 140513056 140513343
  • Product Classification
    Gastroenterology-Urology 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
    Customed Major Laparotomy Pack , convenience pack include multiple components: Mayo stand cover, absorbent towel, bag suture, drape, suction tube, lite glove, gauze/sponges, drape, surgical blades, utility bowls, towels, tube suction, cautery tip, gown, and labels. || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
  • Manufacturer
    Customed, Inc
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