The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-3194-2018·Announced 2018-09-26

Fresenius 2008T Hemodialysis Systems Recalled for Disinfectant Exposure Risk

Fresenius Medical Care is recalling 80 hemodialysis systems because a power failure during cleaning may allow disinfectant to remain in the machine and be delivered to patients.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a medical device that could deliver harmful chemicals to patients falls under the 'Severe' category, particularly given the potential for significant injury from chemical exposure during dialysis.

Plain-English summary

Fresenius Medical Care Renal Therapies Group, LLC is recalling 80 units of the 2008T Hemodialysis System with CDX (Part Number 190713), applicable only with the 2008T BlueStar Premium Upgrade Kit (Part Number 191138). These devices are indicated for acute and chronic dialysis therapy.

The recall is due to a software defect that can occur if a power failure or interruption happens during the cleaning and disinfection program while the auto-start feature is enabled. In this scenario, the machine may enter the dialysis program even though the dialysis program button is disabled and the mandatory rinse has not been performed. This can result in disinfecting chemicals not being completely removed from the machine before treatment begins, potentially allowing disinfectant to exist in the dialysate delivered to the patient.

The affected units were distributed in the United States in the states of California, Connecticut, Michigan, North Carolina, and New York. Specific serial codes for the affected units are listed in the agency's recall record. Healthcare facilities and patients should contact Fresenius Medical Care for instructions on how to address this issue.

The recalled product

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.
Manufacturer
Fresenius Medical Care Renal Therapies Group, LLC
Category
Medical Device — Hemodialysis System
Hazard
Affected units
80

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 3T0S119726
  • 3T0S119741
  • 3T0S119747
  • 3T0S119753
  • 3T0S119762
  • 3T0S119775
  • 3T0S119792
  • 3T0S119801
  • 3T0S119806
  • 3T0S119807
  • 3T0S119818
  • 3T0S119823
  • 3T0S119824
  • 3T0S119848
  • 3T0S119863
  • 3T0S119910
  • 3T0S119948
  • 3T0S119965
  • 3T0S119984
  • 3T0S120097

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Fresenius Medical Care Renal Therapies Group, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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