Fresenius Hemodialysis Blood Lines Recalled for Potential Disconnection Risk
Fresenius Medical Care is recalling 8,528 cases of 2008K@ Home Blood lines due to a risk of disconnection and blood loss if not tightened correctly.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of blood loss from a medical device, which is a significant potential harm, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 8,528 cases of 2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use, Catalog Number 03-2962-3. The product is intended for use as the extracorporeal blood circuit during hemodialysis with conventional and high flux negative pressure hemodialyzer equipment.
The recall is issued because bloodline connections that are not tightened per the instructions in the operator's manual may disconnect, leading to blood loss. The affected units were distributed nationwide in the United States and in Canada.
Patients and healthcare providers should stop using the affected blood lines and contact Fresenius Medical Care for further instructions.
The recalled product
- Product
- 2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use Catalog Number: 03-2962-3. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Affected units
- 8,528
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lot codes
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Fresenius Medical Care Holdings, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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