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2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium...

FDA Device Recall #Z-3194-2018 — Class II — July 13, 2018

Recall Summary

Recall Number Z-3194-2018
Classification Class II — Moderate risk
Date Initiated July 13, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Fresenius Medical Care Renal Therapies Group, LLC
Location Waltham, MA
Product Type Devices
Quantity 80

Product Description

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.

Distribution Pattern

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

Lot / 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

Other Recalls from Fresenius Medical Care Renal Therapie...

Recall # Classification Product Date
Z-2151-2019 Class II Liberty Cycler Cassettes (a disposable cassette... May 29, 2019
Z-1699-2019 Class III 2008T BlueStar Machine Software v.2.72-Hemodial... Apr 3, 2019
Z-0658-2019 Class II Optiflux F160NR Capillary High Flux Dialyzer Si... Nov 5, 2018
Z-0517-2019 Class III Fresenius Granuflo Dry Acid Concentrate- 2K 2.5... Oct 9, 2018
Z-0518-2019 Class III Fresenius Granuflo Dry Acid Concentrate- 3K 2.... Oct 9, 2018

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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