Devices

Device Recall Customed

  • Model / Serial
    Product code 900-1966, 18 lots:  113025951 113026188 113036672 113047210 113067907 113078582 113099405 113109642 113109776 131110111 131110333 131210639 140111088 140211806 140312102 140412625 140412892 140513119
  • 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
    HIGADO & PANCREA PACK - || (1) BAG SUTURE FLORAL || (2) YANKAUER SUCTION TUBE WITHOUT VENT || (4) DRAPE UTILITY WITH TAPE || (6) TOWELS CLOTH HUCK BLUE || (1) SHEET DRAPE 41 " X 58" SMS || (1) MAYO TRAY LARGE || (1) TABLE COVER REINFORCED 50" X 90" || (1) DRAPE INCISE ANTIMICROBIAL 23" X 17" || (1) DRAPE BARIATRIC || (1) BLADE SURGICAL #10 STAINLESS STEEL || (1) CUP SPECIMEN WITH CAP 4oz || (1) BLADE SURGICAL #15 STAINLESS STEEL || (30) LAP SPONGE PREWASH 18" X 18" XRD || (1) STRIP STERI CLOSURE W X 4" || (1) POLISHER CAUTERY TIP || (1) NEEDLE ECLIPSE 22 X 1 Y2 || (4) TOWEL ABSORBENT 15" X 20" || (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK || (2) LITE GLOVE || (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER || (1) COUNTER NDLE/BLADE 60C FOAM/STR/MAG/STR || (1) FORCE TRIVERSE || (1) SYRINGE BULB 60CC || (1) BLADE EXTENDED ELECT. 16.51cm || (2) TUBE SUCTION CONNECT Y." X 12' || (2) CHLORAPREP 26ML APPLICATOR TEAL || (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE || Product Usage: || 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
    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
Device Recall Customed
  • Model / Serial
    Product code 900-080, 37 lots: 109061259 109071681 109091967 109102245 109122679 110020427 110040863 110061419 110081951 111030731 111040866 111061577 111071877 111082180 111092575 111102818 111123295 111123409 111123475 112010012 112020300 112072820 112083049 112093839 112124910 113057408 113078229 113088827 113099264 131110145 131210670 140111082 140211626 140311911 140412449 140513057 140613558
  • 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 Cysto Tur Pack, convenience pack include multiple components: legging with cuff, drape cystoscopy, towel absorbent & table cover. || 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 900-149, 32 lots: 111113165 111123349 112010052 112010280 112030621 112041077 112051768 112062421 112083062 112093900 112104147 112114637 112114952 113015429 113025941 113026204 113036749 113047333 113057861 113078258 113078600 113089192 113109733 131110083 131110399 131110578 131210961 140111409 140211872 140312328 140412830 140513345
  • 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 Laparotomy Pack , convenience pack include multiple components: drape laparot., gown, absorbent towel, scrub, stck sponges/ gauzes, table cover, drape sheet, suture bag, duraprep surgical solution, cloth huck towels, utility bowls, suction tube, scalpel, Mayo Tray, Mayo Cover, & lite gloves. || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
  • Manufacturer
    Customed, Inc
326 more