Device Recall Customed

  • 모델명 / 제조번호(시리얼번호)
    Product code 900-1393, 6 lots: 112041420 113078354 113109651 140211586 140312499 140613718
  • 의료기기 분류등급
  • 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
    OPEN HEART TRAY - - PACK A || ( 1) CV SPLIT DRAPE W/ CLEAR AN EST SCREEN STD SMS LIF || (5) DRAPE % ECONOMY 53" X 77" LIF || ( 1) MAYO STAND COVER REINFORCED LIF || (7) DRAPE UTILITY WITH TAPE L/F || (8) HUCK CLOTH TOWELS WHITE L/F || (20) HUCK CLOTH TOWELS BLUE LIF || (1) MAYO TRAY LARGE LIF || (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF || (6) 3/4 SHEET DRAPE REINFORCED LIF || (2) STOCKINETTE 9" X 48" LIF || (1) SPLIT SHEET BILATERAL 84" X 80" LIF || (3) DRAPE SHEET 41" X 58" SMS LIF || (4) Pr. GLOVES SURGEON #7 BIOGEL || OPEN HEART TRAY - HOSPITAL DAMAS - PACK B- || (1) PLASTIC RULER 12" LONG || (2) SYRINGE 60ML WITHOUT NEEDLE LISLIP L/F || (1) Pk. PEANUT SPONGE DISSECTOR ST. || (2) UTILITY BOWL 32 oz. LIF || (1) SKIN MARKER WITH RULER LIF || (2) UTILITY BOWL 16 oz. UF || (3) BULB SYRINGE 60cc UF || (1) MAYO TRAY SMALL L/F || (2) YANKAUER SUCT. TUBE WITHOUT VENT UF || (1) TRAY ORGANIZER FULL DEEP LIF || (5) SAPHENOUS VEIN CANNULA LIF || (40) LAP SPONGES PRE-WASH XRD UF || (2) ELASTIC BANDAGE 6" X 5 yds. UF || (2) SUTURE BAG FLORAL || (2) NEEDLE & BLADE COUNTER 40c FOAM/MAG UF || (1) BLADE SHARP ALL ARROUND 69 || (1) SURGICAL BLADE# 11 CARBON STEEL || (4) LITE GLOVES UF || (2) SURGICAL BLADE# 15 CARBON STEEL || (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL || (1) SYRINGE 1 cc TUBER 25G X 5/8 S/TIP LIF || (2) POUCH INSTRUMENT || (2) SURGICAL BLADE# 10 CARBON STEEL || (30) GAUZE SPONGES 4" X 4" 16 PLY XRD UF || (2) CAUTERY PENCIL ROCKER SWITCH LIF || (2) POLISHER CAUTERY TIP UF || (1) LABEL SET, HEPARINE,SALINE || (2) ELASTIC BANDAGE 4" X 5 yds. LIF || (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE UF (1) NEEDLE HYPODERMIC 18G X 1% LIF || (2) COTION GLOVE HEAVY DUTY || (1) AORTIC MONITORING PRESS SET 5.0 || (1) CONNECTOR Y 3/8" X 3/8" X 3/8" LIF || (2) NEEDLE HYPODERMIC 22G X 1 % LIF || (1) BLADE 6.1 X 32.3 X 1.0MM || (1) SQUARE TWO PIECE 500cc GRADUATE || (2) CONNECTOR REDUCER || (1) NEEDLE BLADE/KNIFE 3.0MM || 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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