Devices

Device Recall Customed

  • Modèle / numéro de série
    Product code 900-1966, 18 lots:  113025951 113026188 113036672 113047210 113067907 113078582 113099405 113109642 113109776 131110111 131110333 131210639 140111088 140211806 140312102 140412625 140412892 140513119
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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

Fabricant

Customed, Inc
  • Adresse du fabricant
    Customed, Inc, Calle Igualdad Final #7, Fajardo PR 00738
  • Société-mère du fabricant (2017)
    Customed Inc
  • Source
    USFDA

331 dispositifs médicaux avec un nom similaire

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Device Recall Customed
  • Modèle / numéro de série
    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
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Description du dispositif
    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
  • Modèle / numéro de série
    LOTS: SL15210 (150719663) 31-JUL-16 SL15244 (150820222) 31-AUG-16
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Description du dispositif
    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
  • Modèle / numéro de série
    LOT: SL15209 (150719960) 31-JUL-16
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Description du dispositif
    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
  • Modèle / numéro de série
    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
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Description du dispositif
    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
  • Modèle / numéro de série
    Catalog Number: 900012 LOTS: SL15202 (150719606) 31-JUL-16 SL15210 (150720034) 31-JUL-16 SL15219 (150720056) 31-JUL-16
  • Classification du dispositif
    Obstetrical and Gynecological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Description du dispositif
    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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