Device Recall Customed

  • 모델명 / 제조번호(시리얼번호)
    Code 900-2726: 7 lots 131110255 131210799 140111086 140211664 140312141 140412664 140512992
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    REEMPLAZO DE RODILLA Y CADERA || CONTENTS: || (6) TOWELS ABSORBENT 15" X 20" || (I) PK. STRIP STERICLOSURE Y," X 4" || (I) COVER MAYO STAND RErNFORCED || (I) SKIN MARKERINK W/8 LABEIJfiME OUT/RULER || (I) BAG SUTURE FLORAL || (2) SCALPEL WEIGHTED SAFETY # I0 || (I) STOCKrNETTE IMPERV 14" X 48" || (I) TIME OUT BEACON NON WOVEN || (2) DRAPE U 60" X 70"WI TAPE SPLIT 6" X 21 " (2) TUBE SUCTION CONNECT'/.'' X 12' || (2) DRAPE INCISE ANTIMICROBIAL 23" X 17" || (2) LIGHT SHIELD || (I) NEEDLE SPINAL ANESTH 18G X 3 Y, || (4) STR IPS TAPE 24" X 4" || (I ) GOWN IMP. XTRA REINF SMS XL T/W LEVEL || (20)GAUZE SPONGES 4" X 4" 16PLY || (3) DRAPE '!. ECONOMY 53" X 77" || (I) DRAPE UNDERBUTTOCK W/POUCI-1 44" X 35" || (I) DRAPE TOP WIADHESIVE 108" X 50" STD SMS || (I) COUNTER NEEDLE 60C FOAM STRIP/MAG STRIP || (I) YANKAUER OPEN TIP CLEAR W/0 CIV || (2) DRAPE SIDE 36" X 77" W/ADl-1. || (I) SHEET SPLIT W/ADHES 108" X 77" STD SMS || (I) SYRINGE 60ML UL W/0 NEEDLE || (I) POLISHER CAUTERY TIP || (I) NEEDLE BLUNT FILL 1 8G X I Y, || (2) COVER TABLE BTC 77" X I I 0"l-ID FULL COVERAGE || (2) GLOVE SURG. DERMA PRENE #8 POWDER FREE || (10) SPONGE LAP PREWASH 18" X 18" XRD || (I) COVER MAYO STAND W/CSR 23" X 54" || (I) BOWL UTILITY QUART 32oz. || (3) CLAMP TOWEL || (I) BOWL UTILITY PINT 16oz. || (3) GOWN MICROCOOL IMP. XTRA LONG XL || (3) BANDAGE ELASTIC 6" X 5YRD WIVELCRO || (I) MERLING SKrN PREP APPLIC.39ML || (2) PADDING CAST SOFT ROLL 6 X 4YRD || (I) MAYO TRAY LARGE || Product Usage: || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Customed, Inc, Calle Igualdad Final #7, Fajardo PR 00738
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 331 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed only in Puerto Rico.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    LOTS: SL15210 (150719663) 31-JUL-16 SL15244 (150820222) 31-AUG-16
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed only in Puerto Rico.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    LOT: SL15209 (150719960) 31-JUL-16
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed only in Puerto Rico.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distributed only in Puerto Rico.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number: 900012 LOTS: SL15202 (150719606) 31-JUL-16 SL15210 (150720034) 31-JUL-16 SL15219 (150720056) 31-JUL-16
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed only in Puerto Rico.
  • 제품 설명
    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
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