Devices

Device Recall Customed

  • 모델명 / 제조번호(시리얼번호)
    Product code 900-796, 14 lots: 113047032 113057507 113067965 113078346 113088892 113109873 131110279 131210842 140111251 140211700 140311949 140312388 140513145 140513340
  • 의료기기 분류등급
    Cardiovascular Devices
  • 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
    FEMORAL ANGIOGRAPHY PACK - || (1) TABLE COVER REINFORCED 50" X 90" UF || (1) GOWN LARGE SMS IMPERVIOUS REINFORCED LIF || (1) TOWEL ABSORBENT 15" X 20" UF || (1) DRAPE ANGlO 75" X 145" || (4) TOWELS CLOTH HUCK (BLUE) UF || (3) SYRINGE 1 Occ WITHOUT NEEDLE LUER LOCK UF || (1) IV ADM SET 15ML 1 06" LONG LIF || (20) GAUZE SPONGE 4" X 4" 12PL Y LIF || (1) NEEDLE HYPODERMIC 18G X 1Y:. ST. UF || (1) NEEDLE HYPODERMIC 21G X 1Y:. ST. LIF || (2) MEDICINE CUP 2oz. CLEAR LIF || (1) SCALPEL WEIGHTED SAFETY #11 || (2) CHLORASCRUB SWABSTICK 5.1 ML LIF || (1) GOWN SURG REINFORCED LARGE TOWEL/WRAP LIF || (1) SPECIMEN CONTAINER 4oz. W/LID & LABEL LIF || (1) NEEDLE HYPODERMIC 25G X 5/8 ST. LIF || (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF || (1) FORCEP ADS ON TISS. WITH TIP LIF || (1) UTILITY BOWL 32oz LIF || (1) UTILITY BOWL 16oz L/F || (1) FORCEP KELLY STRAIGHT 5.5" LIF || (1) MOSQUITO HALSTED CVD 5" LIF || (1) TRAY ORGANIZER FULL DEEP LIF || (1) SCISSOR MAYO 6.75 STRAIGHT LIF || (1) HOLDER NEEDLE WEBSTER 4.75 LIF || (1) GUIDEWIRE .035" X 150cm UF || (1) TIME OUT BEACON NON WOVEN ST. UF || (1) MAYO TRAY SMALL LIF || (2) TOWEL CLAMP UF || (2) BAG BAND RUBBAND & TAPE LIF || (1) Pr. GLOVE SURG. #7Y:. DERMA PRENE P/F LIF || (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF || LABEL SAMPLE || (1) NEEDLE & BLADE COUNTER 60C FOAM STRIP/MAG STRIP LIF || (1) NEEDLE 18G X 2 o/.i AMC/4 || (1) SKIN MARKER INK WITH/8 LABEL || 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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