CLASS II Device recall · Reported 13 Apr 2016 · FDA Enforcement Report
Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T recalled
Fresenius Medical Care Renal Therapies Group is recalling Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home, distributed nationwide in the US. The recall was initiated on 10 Mar 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1325-2016
- FDA event ID
- 73487
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, Waltham, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Mar 2016
- FDA classified
- 5 Apr 2016
- Reported
- 13 Apr 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 10 Mar 2016 | Recall initiated by company | |
| 5 Apr 2016 | Classified by FDA | +26 days |
| 13 Apr 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Added Warning Statement: Fresenius 2008 Series Hemodialysis Machines False Blood Leak Alarm When Dialyzing Patients Treated with Hydroxocobalamin (or any form of Vitamin B-12)
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: Models: Fresenius 2008K and 2008K2 Dialysate Delivery System Fresenius 2008K@home Hemodialysis Machine with bibag System 2008T Hemodialysis Machine The Fresenius 2008¿ Series Machines are indicated for acute and chronic dialysis therapy
Where it was distributed
Nationwide Distribution
Questions about this recall
Why was it recalled?
Added Warning Statement: Fresenius 2008 Series Hemodialysis Machines False Blood Leak Alarm When Dialyzing Patients Treated with Hydroxocobalamin (or any form of Vitamin B-12)
Which lots are affected?
Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: Models: Fresenius 2008K and 2008K2 Dialysate Delivery System Fresenius 2008K@home Hemodialysis Machine with bibag System 2008T Hemodialysis Machine
Where was it sold?
Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Fresenius Medical Care Renal Therapies Group
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|---|---|---|---|---|---|
| Device | CLASS II | CombiSet Hemodialysis Blood Tubing Set recalled | Fresenius Medical Care Renal Therapies Group | Other | Nationwide |
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