Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 20, 2013
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.
Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Fresenius Medical Care Holdings, Inc. recalled 2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use Catalog Number: 0… - a moderate-severity action.
2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use Catalog Number: 0… was recalled by Fresenius Medical Care Holdings, Inc. in November 20, 2013. Reason: Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual m…. Check the official notice for the remedy. Verify recall #Z-0184-2014 with the FDA Devices before acting.
The recall
Fresenius Medical Care Holdings, Inc. issued this moderate-severity FDA Devices recall-Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual m….
- Moderate
- severity level
- Class II
- classification
- November 20, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0184-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0184-2014) was formally reported on November 20, 2013, with the manufacturer initiating the action on August 29, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Fresenius Medical Care Holdings, Inc. is listed as the recalling firm, operating out of Waltham, MA. Federal records list the affected scope as 8,528 cases.
The documented reason for this recall is: Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss Distribution data in the federal record shows the product reached: Worldwide Distribution-USA (nationwide) and the country of Canada.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
8,528 cases
Related Recalls
6
3 from same agency
Product description
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.
Reason for recall
Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0184-2014 |
| Date reported | November 20, 2013 |
| Date initiated | August 29, 2013 |
| Recalling firm | Fresenius Medical Care Holdings, Inc. |
| Firm location | Waltham, MA |
| Affected scope | 8,528 cases |
| Distribution | Worldwide Distribution-USA (nationwide) and the country of Canada. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0184-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 8,528 cases.
Why was this product recalled? ▼
Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 20, 2013. Severity: Moderate. Recall number: Z-0184-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution-USA (nationwide) and the country of Canada..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0184-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 20, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.