Class 2 Device Recall 2008T BlueStar Hemodialysis Machine

• Date Initiated by Firm: July 13, 2018
• Create Date: September 19, 2018
• Recall Status: Terminated on September 17, 2019
• Recall Number: Z-3194-2018
• Recall Event ID: 80875
• 510(K)Number: K173972
• Product Classification: Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
• 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.
• Code Information: 3T0S119726, 3T0S119741, 3T0S119747, 3T0S119753, 3T0S119762, 3T0S119775, 3T0S119792, 3T0S119801, 3T0S119806, 3T0S119807, 3T0S119818, 3T0S119823, 3T0S119824, 3T0S119848, 3T0S119863, 3T0S119910, 3T0S119948, 3T0S119965, 3T0S119984, 3T0S120097, 3T0S120134, 3T0S120200, 1T0S104090 1T0S104108 1T0S104116 1T0S104166 1T0S104169 1T0S104188 1T0S104189 1T0S104191 1T0S104216 1T0S104224 1T0S104240 1T0S104249 1T0S104278 1T0S104293 1T0S104303 1T0S104310 1T0S104324 1T0S104325 1T0S104334 1T0S104357 3T0S121680 4T0S126717 4T0S126764 4T0S126782 0T0S101039 0T0S101123 0T0S101144 0T0S101182 0T0S101197 0T0S101220 0T0S101231 0T0S101232 0T0S101236 0T0S101238 0T0S101240 0T0S101252 0T0S101298 0T0S101324 0T0S101329 0T0S101341 0T0S101344 0T0S101345 0T0S101352 3T0S118641 3T0S118661 3T0S118662 3T0S118670 3T0S118675 3T0S118682 3T0S118695 3T0S118698 3T0S118699 3T0S118702 3T0S118703 3T0S118721 3T0S118723 3T0S118726 3T0S118734 3T0S118754
• Recalling Firm/ Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC; 920 Winter St; Waltham MA 02451-1521
• For Additional Information Contact: Fresenius Technical Service; 800-227-2572
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Under Investigation by firm
• Action: On 07/13/2018 phone calls were immediately conducted to the affected clinics. Contact was made to the Technical Service Directors explaining issue and to disable the Auto Start Function on their BlueStar SW v2.71 installed 2008T Hemodialysis Machines.
• Quantity in Commerce: 80
• Distribution: US Nationwide in the states of : CA, CT, MI, NC, and NY.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KDI and Original Applicant = Fresenius Medical Care Renal Therapies Group, LLC