Reported Nov 20, 2013 · Terminated
2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use Catalog Number: 03-2962-3. Intended for use as…
Fresenius Medical Care Holdings, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fresenius Medical Care Holdings, Inc. · 920 Winter St · Waltham, MA · 02451-1521
Is this the product you have?
- 2008K@ Home Blood lines Combiset True Flow Series
- for Hemodialysis use Catalog Number03-2962-3. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment
- Lot codes and dates
- All lot codes
- Amount recalled
- 8,528 cases
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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