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
Reported: April 13, 2016 Initiated: March 10, 2016 #Z-1325-2016
Product Description
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
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)
Details
- Recalling Firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Units Affected
- 8384 units (8369 US) (15 OUS)
- Distribution
- Nationwide Distribution
- Location
- Waltham, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Fresenius Medical Care Renal Therapies Group, LLC. Units affected: 8384 units (8369 US) (15 OUS).
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on April 13, 2016. Severity: Moderate. Recall number: Z-1325-2016.
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