Broselow/Hinkle Pediatric Emergency System

  • 모델명 / 제조번호(시리얼번호)
    Expiration for kit is four years.   Oz Masks  #D075986 Class I Exempt Device  If you have purchased directly from Vital Signs, the product codes affected are: 7700BAW2, 7700GAW2, 7700OAW2, 7700PAW2, 7700RAW2, 7700WAW2, 7700YAW2, Kits with masks included: 7730ALS, 7730BLU5, 7730FLY, 7730GRN5, 7730IALS, 7730MOD, 7730ORG5, 7730PUR5, 7730RED5, 7730WHI5, 7730YEL5. If you have purchased directly from Armstrong Medical, the Product Codes affected are: AE-4700 AE-4712, AE-4701, 7730RED, 7730PUR, 7730YEL, 7730WHI, 7730BLU, 7730ORG, 7730GRN, 7700RAW, 7700PAW, 7700YAW, 7700WAW, 7700BAW, 7700OAW, 7700GAW " Lot numbers of the affected modules are: 2009 K109 through K365 2010 P001 through P149510 (k) : K781055; Medical Device Listing   Blood Pressure Cuffs  If you have purchased directly from Vital Signs, the product codes affected are: BP4030BR, BP4530BR, 7730POCH, 7730IALS If you have purchased directly from Armstrong Medical, the product codes affected are: AE-4703, AE- 4700, AE-4706, AE-4707 " Lot numbers affected are: For the year 2009 LOT Number 2689 through LOT Number 3659 For the year 2010 LOT Number 0010 through LOT Number 2530 Any lot number that ends in the number 1 is NOT affected by the recall.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    IL
  • 제품 설명
    Broselow/Hinkle Pediatric Emergency System, Vital Signs Inc., 20 Campus Road, Totowa, NJ 07512 USA || The kit contains oxygen masks and blood pressure cuffs use on pediatric patients
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Vital Signs Devices, a GE Healthcare Company, 20 Campus Rd, Totowa NJ 07512-1210
  • 제조사 모회사 (2017)
  • Source
    USFDA

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  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 7700GAW2 (Lot serial: LOT 2389 - 3659); Model Catalog: 7700OAW2 (Lot serial: LOT 2389 - 3659); Model Catalog: 7700PAW2 (Lot serial: LOT 2389 - 3659); Model Catalog: 7700RAW2 (Lot serial: LOT 2389 - 3659); Model Catalog: 7700WAW2 (Lot serial: LOT 2389 - 3659); Model Catalog: 7700YAW2 (Lot serial: LOT 2389 - 3659); Model Catalog: 7700BAW2 (Lot serial: LOT 0010 - 2530); Model Catalog: 7700BAW2 (Lot serial: LOT 2389 - 3659); Model Catalog: 7700YAW2 (Lot serial: LOT 0010 - 2530); Model Catalog: 7700WAW2 (Lot serial: LOT 0010 - 2530); Model Catalog: 7700RAW2 (Lot serial: LOT 0010 - 2530); Model Catalog: 7700PAW2 (Lot serial: LOT 0010 - 2530); Model Catalog: 7700OAW2 (Lot serial: LOT 0010 - 2530); Model Catalog: 7700GAW2 (Lot serial: LOT 0010 - 2530); Model Catalog: BP4530BR (Lot serial: LOT 0010 - 2530); Model Catalog: 7730FLY (Lot serial: LOT 2389 - 3659); Model Catalog: BP4530BR (Lot serial: LOT 2389 - 3659); Model Catalog: BP4030BR (Lot serial: LOT 2389 - 3659); Model Catalog: 7730POCH (Lot seria
  • 제품 설명
    Broselow Pediatric Emergency System Kit
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 7700GIV2 (Lot serial: > 10 numbers contact mfg); Model Catalog: 7700OIV2 (Lot serial: > 10 numbers contact mfg); Model Catalog: 7700BIV2 (Lot serial: > 10 numbers contact mfg); Model Catalog: 7700WIV2 (Lot serial: > 10 numbers contact mfg); Model Catalog: 7700YIV2 (Lot serial: > 10 numbers contact mfg); Model Catalog: 7700PIV2 (Lot serial: > 10 numbers contact mfg); Model Catalog: 7700RIV2 (Lot serial: > 10 numbers contact mfg); Model Catalog: 7730MOD (Lot serial: > 10 numbers contact mfg); Model Catalog: 7730IALS (Lot serial: > 10 numbers contact mfg); Model Catalog: 7730ALS (Lot serial: > 10 numbers contact mfg); Model Catalog: 7730GRN5 (Lot serial: > 10 numbers contact mfg); Model Catalog: 7730ORG5 (Lot serial: > 10 numbers contact mfg); Model Catalog: 7730BLU5 (Lot serial: > 10 numbers contact mfg); Model Catalog: 7730WHI5 (Lot serial: > 10 numbers contact mfg); Model Catalog: 7730YEL5 (Lot serial: > 10 numbers contact mfg); Model Catalog: 7730PUR5 (Lot serial: > 10 numbers contact mfg); M
  • 제품 설명
    BROSELOW/HINKLE PEDIATRIC EMERGENCY SYSTEM IV MODULE
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 7730PUR5 (Lot serial: 001K to 149K inclusive); Model Catalog: 7730RED5 (Lot serial: 001K to 149K inclusive); Model Catalog: 7730ORG5 (Lot serial: 001K to 149K inclusive); Model Catalog: 7730MOD (Lot serial: 001K to 149K inclusive); Model Catalog: 7730IALS (Lot serial: 001K to 149K inclusive); Model Catalog: 7730GRN5 (Lot serial: 001K to 149K inclusive); Model Catalog: 7730BLU5 (Lot serial: 001K to 149K inclusive); Model Catalog: 7730ALS (Lot serial: 001K to 149K inclusive); Model Catalog: 7730YEL5 (Lot serial: 245F to 366F inclusive); Model Catalog: 7730WHI5 (Lot serial: 245F to 366F inclusive); Model Catalog: 7730RED5 (Lot serial: 245F to 366F inclusive); Model Catalog: 7730PUR5 (Lot serial: 245F to 366F inclusive); Model Catalog: 7730ORG5 (Lot serial: 245F to 366F inclusive); Model Catalog: 7730MOD (Lot serial: 245F to 366F inclusive); Model Catalog: 7730IALS (Lot serial: 245F to 366F inclusive); Model Catalog: 7730GRN5 (Lot serial: 245F to 366F inclusive); Model Catalog: 7730BLU5 (Lot seria
  • 제품 설명
    BROSELOW/HINKLE PEDIATRIC SYSTEM KIT
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Model Numbers: 7700BIO, 7700GIO, 7700PIO, 7700RIO, 7700WIO, 7700YIO, 7700BIO2, 7700GIO2, 7700OIO2, 7700PIO2, 7700RIO2, 7700WIO2, 7700YIO2, 7730BLU5, 7730GRN5, 7730ORG5, 7730PUR5, 7730RED5, 7730WHI5, 7730YEL5, 7730FLY, 7730MOD, 7730ALS and 7730IALS; and Lot Numbers: (2008) 245F through 366F and (2009) 001K through 149K.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US, Canada, United Arab Emirate, Venezuela, Guam, Korea and United Kingdom.
  • 제품 설명
    Broselow/Hinkle Pediatric Emergency System; || Contents: 1 15 Ga Adjustable Length Sternal/Iliac aspiration Needle; 1 Extension Set, Sterile. Equipment Color Zone: Green, Single Patient use, || INTRAOSSEUS Module, Product # 7700GIO, Vital Signs, Totowa, NJ. || The Broselow/Hinkle Pediatric Emergency System is a convenience kit that contains various modules/components used for the emergency treatment of pediatric patients. The modules are color coded to accommodate patients of various sizes.
  • Manufacturer