2008T HEMODIALYSIS SYS — Class II medical device recall Z-3194-2018
Terminated recall by Fresenius Medical Care Renal Therapies Group, LLC, reported 2018-09-26, distributed nationwide. In the hemodialysis machine during the cleaning/disinfection program, when there is a power failure or interru
| Recall number | Z-3194-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Renal Therapies Group, LLC, Waltham, MA, United States |
| Recall initiated | 2018-07-13 |
| Classified | 2018-09-18 |
| Reported by FDA | 2018-09-26 |
| Terminated | 2019-09-17 |
| Distributed | Nationwide (US) |
| Quantity | 80 |
| Reason classes | chemical contamination |
| Model numbers | 190713, 191138 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3194-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.