Combiset Blood Line Hemodialysis use Catalog Number: 03-2622-3 — Class II medical device recall Z-0186-2014
Terminated recall by Fresenius Medical Care Holdings, Inc., reported 2013-11-20, distributed nationwide. Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual ma
| Recall number | Z-0186-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Holdings, Inc., Waltham, MA, United States |
| Recall initiated | 2013-08-29 |
| Classified | 2013-11-08 |
| Reported by FDA | 2013-11-20 |
| Terminated | 2021-02-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 508,029 cases |
| Model numbers | 03-2622-3 |
Product
Combiset 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 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0186-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.