Devices

Device Recall Customed

  • 모델명 / 제조번호(시리얼번호)
    Product code 900-2005, 14 lots: 111123199 112030704 112041279 112051918 112083420 112125056 113036459 113047202 113057860 113078296 113088780 113109780 140211726 140412462
  • 의료기기 분류등급
    Obstetrical and Gynecological 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
    CESAREAN PACK - || (1) BABY BLANKET IMP. POLY ABS. || (4) ABSORBENT TOWELS 15" x 20" LIF || (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF || (2) LITE GLOVES LIF || (1) BOWL PLASTIC WITH LID 80 oz. || (1) C-SECTION DRAPE W/ POUCH 102" X 121 " X 78" || (1) UTILITY BOWL 32 oz. || (10) LAP SPONGES PRE-WASHED XRD LIF || (2) PAD OBSTETRICAL XLGE || (1) BABY BEANNIES || (1) MAYO STAND COVER REINFORCED L/F || (1) DRAPE SHEET 41" X 58" SMS LIF || (1) TUBE SUCTION CONNECT. X" X 12' L/F || (1) EAR ULCER SYRINGE 2oz. LIF || (1) RECEIVING BLANKET 100% COTION || (1) YANKAUER SUCT TUBE WITHOUT VENT L/F || (1) UMBILICAL CORD CLAMP || (2) WRAPPER 20"X 20" || (1) DRESSING ISLAND 4" X 10" || (1) SCALPEL# 10 WITH HANDLE S/S || (1) SCALPEL# 20 WITH HANDLE || (1) TABLE COVER REINFORCED 50" X 90" L/F || (1) MAYO TRAY SMALL || (1) MUCUSTRAP 20cc 1 OFr. || (2) GOWN LGE SMS IMPERVIOUS REINFORCED || (1) SURGICAL DURAPREP SOLUTION 26mL L/F || 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: 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
    General and Plastic Surgery Devices
  • 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
    Customed, Inc
Device Recall Customed
  • 모델명 / 제조번호(시리얼번호)
    LOTS: SL15210 (150719663) 31-JUL-16 SL15244 (150820222) 31-AUG-16
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 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
    Customed, Inc
Device Recall Customed
  • 모델명 / 제조번호(시리얼번호)
    LOT: SL15209 (150719960) 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: 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
  • 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
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