Home / Recalls / Fresenius Medical Care Renal Therapies Group, LLC / Z-0517-2019

Z-0517-2019 Class III Terminated

Recalled by Fresenius Medical Care Renal Therapies Group, LLC — Waltham, MA

Recall Details

Product Type
Devices
Report Date
December 5, 2018
Initiation Date
October 9, 2018
Termination Date
August 5, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
92225

Product Description

Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B for hemodialysis

Reason for Recall

Discolored powder has confirmed the presence of a foreign substance

Distribution Pattern

Distribution US nationwide and Mexico

Code Information

Lot code: 18ETGF010 18HTGF002 18HTGF003 18HTGF007 18HTGF011 18HTGF013 18HTGF016 18JTGF005 18JTGF010 18JTGF012 18KTGF001 18KTGF011

Other recalls by Fresenius Medical Care Renal Therapies Group, LLC

  • Z-2151-2019 Class II — Liberty Cycler Cassettes (a disposable cassette that is intended to be used to p (May 29, 2019)
  • Z-1699-2019 Class III — 2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 1911 (April 3, 2019)
  • Z-0658-2019 Class II — Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 05003 (November 5, 2018)
  • Z-0516-2019 Class III — Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number (October 9, 2018)
  • Z-0518-2019 Class III — Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Num (October 9, 2018)
  • Z-3195-2018 Class II — 2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2008 (July 13, 2018)
  • Z-3194-2018 Class II — 2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T (July 13, 2018)
  • Z-2110-2018 Class II — NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part (May 2, 2018)
  • Z-1365-2018 Class II — Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: (January 24, 2018)
  • D-0604-2018 Class II — DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in (December 20, 2017)