Devices

Device Recall Fresenius NaturaLyte

  • Model / Serial
    Affected lots begin with: 14DMLB, 14EMLB, 14HMLB, 14JMLB, 14KMLB, 14LMBL, 14NMLB, 14PMLB, and 14SMLB.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    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

Manufacturer

Fresenius Medical Care Holdings, Inc.
  • Manufacturer Address
    Fresenius Medical Care Holdings, Inc., 920 Winter St, Waltham MA 02451-1521
  • Manufacturer Parent Company (2017)
    Fresenius SE & Co KGaA
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

Device Recall Fresenius Naturalyte Liquid Acid Concentrate
  • Model / Serial
    Lot Number: 15STAC072 Exp Date: 2017-12-31
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to states of: KS, LA, MS, OK, and TX.
  • Product Description
    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
  • Model / Serial
    All lots
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution and the country of Guam.
  • Product Description
    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.