19

Sep

2018

Recall – Cl II 2008T HEMODIALYSIS SYSTEM W/BIBAG

0

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

PRODUCT

2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: Indicated for acute and chronic dialysis therapy.

Recall Number: Z-3195-2018

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

VOLUME OF PRODUCT IN COMMERCE
40

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

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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