Fresenius 2008T Hemodialysis System Recalled for Disinfectant Exposure Risk
Fresenius Medical Care is recalling 40 units of the 2008T Hemodialysis System because a power failure during cleaning could leave disinfectant in the dialysate 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves the potential delivery of disinfectant to patients, which is a risk-of-harm product scenario where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Fresenius Medical Care Renal Therapies Group, LLC is recalling 40 units of the 2008T Hemodialysis System with BiBag (Part Number 190766), which is applicable only with the 2008T BlueStar Premium Upgrade Kit (Part Number 191138). The product is indicated for acute and chronic dialysis therapy.
The recall is due to a software defect that occurs if a power failure or interruption happens during the cleaning and disinfection program while the auto-start feature is enabled. In this specific 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 failure could result in disinfecting chemicals not being completely removed from the machine, 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 lot codes are listed in the agency documentation. Consumers and healthcare facilities should contact the manufacturer for instructions on how to address this issue.
The recalled product
- 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.
- Affected units
- 40
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 (10)
- 6T0S160600
- 6T0S160624
- 6T0S160672
- 6T0S160695
- 6T0S160732
- 6T0S160740
- 6T0S160773
- 6T0S160781
- 6T0S160785
- 6T0S160841
Distribution
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.
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