Combiset Blood Line with BVM for Hemodialysis use recallZ-0185-2014 · Fresenius Medical Care Holdings, Inc. · initiated Aug 29, 2013
Class II Terminated All recalls posted in November 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Fresenius Medical Care Holdings, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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
FDA root cause category: Labeling design
What the company is doing
Fresenius issued a Field Notification Letter dated 8/29/13 to Patient Clinics/ associated at home patients and provides additional detail instructions to ensure the connection to the transducer protector bloodline female luer interface is secure. This field advisory notice sent by Certified Mail, Return Receipt Requested. Accounts requested to return both the receipt and the completed reply form (enclosed) to confirm receipt of the notice. If you have any questions regarding this field advisory, please contact FMCNA Customer Service Team at 1-800-323-5188. Customer Service will be available Monday-Friday 7am-6pm CST.
Recall details
- Recall number
- Z-0185-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 29, 2013
- Posted by the FDA
- Nov 8, 2013
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Quantity
- 24,202 cases
- Product code
- ONW
- FDA submissions
- K070049
- Distribution
- Worldwide Distribution-USA (nationwide) and the country of Canada.
Product description
Combiset Blood Line with BVM for Hemodialysis use Catalog Number: 03-2965-9. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
Code information (models, lots, serial numbers)
All lot codes
Other devices under the same FDA submission
2 devices cleared under K070049 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- 2008® Series Hemodialysis Machines 190828Fresenius Usa, Inc. · Hemodialysis system for home use2 recalls8 reports
- CombiSet 03-2962-3Fresenius Medical Care Holdings, Inc. · Hemodialysis system for home use3 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 65739).
- Z-0184-2014 · Terminated2008K@ 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 i…
- Z-0186-2014 · TerminatedCombiset Blood Line Hemodialysis use Catalog Number: 03-2622-3. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventiona…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page