Recall – WITH CDX Cl II 2008T HEMODIALYSIS SYS

Company:Fresenius Medical Care Renal Therapies Group, LLC
Date of Enforcement Report 9/26/2018
Class lI:

PRODUCT

2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: Indicated for acute and chronic dialysis therapy
Recall Number: Z-3194-2018

REASON
In the hemodialysis machine during the cleaning/disinfection program, when there is a power failure or interruption, the dialysis program button should be greyed out when the machine is powered up and a mandatory rinse should be required. However, if a power failure or interruption occurs during the cleaning/disinfection program with the auto-start feature enabled, the machine enters the dialysis program even though the dialysis program button is disabled and the mandatory rinse has not been performed. As a result, disinfecting chemical may not be completely removed from the machine before starting a treatment and disinfectant could exist in the dialysate delivered to the patient. .

RECALLING FIRM/MANUFACTURER
Fresenius Medical Care Renal Therapies Group, LLC, Waltham, MA on 7/13/2018 Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
80

DISTRIBUTION
US Nationwide in the states of : CA, CT, MI, NC, and NY.

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Partners located in the US (CA, FL, MA, MN) and Italy.