Devices

Device Recall Customed

  • 모델명 / 제조번호(시리얼번호)
    Code 900-2918, 8 lots 113047023 113057703 113068037 113078429 113078733 113109799 140312147 140613795
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 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
    TLIF PACK || SURGICAL CENTER, CODE 900-2918. || CONTENTS: || (2) SOLUTION SURGICAL DURAPREP 26ML UF || (6) Pr. GLOVE SURG. DERMA PRENE # 8 PF UF || (4) GOWN SOFT SMS STD XL SET IN SLEEVE UF || (4) TOWELS ABSORBEN 15" X 20" LIF || (1) TABLE COVER REINFORCED 50" X 90" LIF || (1) MAYO STAND COVER REINFORCED LIF || (4) DRAPE% 60" X 76" REINFORCED L/F || (1) DRAPE CHEST 100" X 142" X 72" LIF || (1) FLUORO COVER 30" X 30" WITH RUBBBAND LIF || (2) LITE GLOVE LIF || (2) TUBE SUCTION CONNECT. Y." X 12' UF || (12) TOWELS CLOTH HUCK BLUE LIF || (1) UTILITY BOWL QUART 32oz || (10) GAUZE SPONGE 4" X 4" 16PLY XRD UF || (5) LAP SPONGE PREWASH 18" X 18" XRD LIF || (1) CAUTERY PENCIL ROCKER SWITCH WITH HOLSTER LIF || (1) STERI STRIP DRAPE LARGE 17" X 23" LIF || (1) SKIN MARKER WITH RULER UF || (9) LABELS FOR SKIN MARKERS 1.25 X Y2 || (1) RULER || (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG L/F || (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF || (2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF || (1) BULB SYRINGE 60cc LIF || (4) NEEDLE HYPODERMIC 18G X 1Y2 UF || (1) NEEDLE HYPODERMIC 22G X 1Y2 LIF || (2) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK UF || (1) NEEDLE SPINAL 18G X 6" LONG LENGTH LIF || (1) BLADE SURGICAL # 10 CARBON STEEL || (1) BLADE SURGICAL # 15 CARBON STEEL || (1) TIME OUT BEACON NON WOVEN UF || (2) DRESSING TEGADERM 4" X 4% "UF || (2) MEDICINE CUP 2oz || (1) DRAPE IOBAN INCISE 2 ANTIMICROBIAL 23" X 23" LIF || Product Usage: || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
  • Manufacturer
    Customed, Inc
  • 1 Event

제조사

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

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

데이터에 대해 더 자세히 알아보기 여기

Device Recall Customed
  • 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
    General and Plastic Surgery Devices
  • 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
    Customed, Inc
Device Recall Customed
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number: 900012 LOTS: SL15202 (150719606) 31-JUL-16 SL15210 (150720034) 31-JUL-16 SL15219 (150720056) 31-JUL-16
  • 의료기기 분류등급
    Obstetrical and Gynecological Devices
  • 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
    Customed, Inc
Device Recall Customed
  • 모델명 / 제조번호(시리얼번호)
    LOTS: SL15180 (150619409) 31-MAY-16 SL15181 (150619409) 31-MAY-16 SL15197 (150719607) 31-MAY-16 SL15201-01 (150719607) 31-MAY-16 SL15230 (150820136) 31-AUG-16 SL15251 (150820136) 31-AUG-16 SL15265 (150920652) 30-SEP-16 SL15266 (150920652) 30-SEP-16
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distributed only in Puerto Rico.
  • 제품 설명
    Catalog Number: 900020 IRRIGATION TRAY WITH IRRIGATION BULB SYRINGE || 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
  • 모델명 / 제조번호(시리얼번호)
    LOTS: SL15194 (150719926) 31-JUL-16 SL15194 (150719927) 31-JUL-16 SL15195-02 (150719927) 31-JUL-16 SL15195-02 (150719926) 31-JUL-16 SL15258 (150719926) 31-JUL-16 SL15258 (150719927) 31-JUL-16
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed only in Puerto Rico.
  • 제품 설명
    Catalog Number: 900028 LAPAROSCOPY SURGICAL PACK
  • Manufacturer
    Customed, Inc
Device Recall Customed
  • 모델명 / 제조번호(시리얼번호)
    LOTS: SL15173 (150619057) 30-JUN-16 SL15174 (150619057) 30-JUN-16 SL15175 (150619057) 30-JUN-16 SL15209 (150719928) 31-JUL-16 SL15210 (150719928) 31-JUL-16 SL15216 (150719928) 31-JUL-16 SL15224 (150820057) 31-AUG-16 SL15229 (150820057) 31-AUG-16 SL15258 (150920726) 30-SEP-16 SL15259 (150920726) 30-SEP-16 SL15260 (150920726) 30-SEP-16
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed only in Puerto Rico.
  • 제품 설명
    Catalog Number: 900032 UNIVERSAL DRAINAGE TRAY || 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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