Devices

Device Recall Fresenius NaturaLyte

  • 모델명 / 제조번호(시리얼번호)
    Affected lots begin with: 14DMLB, 14EMLB, 14HMLB, 14JMLB, 14KMLB, 14LMBL, 14NMLB, 14PMLB, and 14SMLB.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle || Catalog Number: 08-4000-LB || This concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
  • Manufacturer
    Fresenius Medical Care Holdings, Inc.
  • 1 Event

제조사

Fresenius Medical Care Holdings, Inc.
  • 제조사 주소
    Fresenius Medical Care Holdings, Inc., 920 Winter St, Waltham MA 02451-1521
  • 제조사 모회사 (2017)
    Fresenius SE & Co KGaA
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 2 건

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Device Recall Fresenius Naturalyte Liquid Acid Concentrate
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 15STAC072 Exp Date: 2017-12-31
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to states of: KS, LA, MS, OK, and TX.
  • 제품 설명
    Fresenius Naturalyte Liquid Acid Concentrate || Catalog Number: 08-2301-3 || Intended Use: Acid Concentrate for Bicarbonate Dialysis
  • Manufacturer
    Fresenius Medical Care Renal Therapies Group, LLC
Device Recall Fresenius NaturaLyte Liquid Acid Concentrate
  • 모델명 / 제조번호(시리얼번호)
    All lots
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution and the country of Guam.
  • 제품 설명
    Fresenius NaturaLyte Liquid Acid Concentrate || Product Codes: || 08-0231-4, 08-1001-0, 08-1201-8, 08-1231-3, 08-1251-1, 08-1301-4, 08-2201-5, 08-2231-2, 08-2251-0, 08-2301-3,08-2351-8,08-3201-4,08-3231-1,08-3251-9,08-3301-2,08-4123-1, 08-4223-7, 08-4225-1' 08-4230-2, 08-4231-0, 08-4323-5, 08-4325-1, 13-1251-1, 13-2201-5, 13-2231-2, 13-2251-0, || 13-3231-1,13-3251-9, 13-4123-1' 13-4220-1, 13-4225-1 ' 13-4325-1. || For the treatment of acute and chronic renal failure during hemodialysis procedure.
  • Manufacturer
    Fresenius Medical Care Holdings, Inc.