Home / Recalls / Medivators, Inc. / Z-1859-2021

Z-1859-2021 Class II Terminated

Recalled by Medivators, Inc. — Plymouth, MN

Recall Details

Product Type
Devices
Report Date
June 23, 2021
Initiation Date
April 20, 2021
Termination Date
July 11, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,381 CASES

Product Description

Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine.

Reason for Recall

The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.

Distribution Pattern

US Nationwide distribution in the states of IA, IL, MN, ND, NY, OH, SD,WI.

Code Information

Lot 489224

Other recalls by Medivators, Inc.

  • Z-1774-2020 Class II — Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXTU, packaged as Conte (October 9, 2019)
  • Z-1777-2020 Class II — Medivators EndoGator REF 100651. Kit for Olympus 140/160/180/190 Series GI Endo (October 9, 2019)
  • Z-1772-2020 Class II — Medivators Endo Smartcap Endoscope Tubing. REF100145. Packaged as Contents 1, (October 9, 2019)
  • Z-1776-2020 Class II — Medivators EndoGator REF 100650. Kit for Olympus 140/160/180/190 Series GI Endo (October 9, 2019)
  • Z-1778-2020 Class II — Medivators Endo carry-on Procedure Kit REF CPK-100222-0002 - Product Usage: is (October 9, 2019)
  • Z-1775-2020 Class II — Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXT, packaged as Conten (October 9, 2019)
  • Z-1773-2020 Class II — Medivators Endo Smartcap Endoscope Tubing. REF100145CO2, packaged as Contents (October 9, 2019)
  • Z-2761-2015 Class II — Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene oxid (August 3, 2015)